1% Nanocurcumin Oral Gel for Oral Lichen Planus—A Positive 4-Week Add-on Lesion Result in Only 31 Participants

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich topical add-on question is covered?Required	The original question concerns improvement of REU lesion scores in symptomatic oral lichen planus. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus	Material needed: Curcumin monotherapy and steroid replacement are outside this comparison. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat is the 1% nanomicellar oral gel?Required	The intervention is a 1% oral gel containing nanomicellar curcumin derived from Curcuma longa. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Composition, nanomicelles, manufacture and active amount of the 1% formulation	Material needed: Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre swallowed formulations distinguished from topical application?Required	The route is topical application to oral lesions. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Local application to lesions and the scope of swallowing/absorption	Material needed: This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionDoes application 3 times daily specify the total active dose?Required	The recorded schedule is application 3 times daily. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Application frequency, amount per application and adherence	Material needed: Daily mg, amount per application and absorbed amount are not calculated from 1% concentration and application 3 times daily. Application amount and adherence remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionDoes 4 weeks describe both treatment and follow-up?Required	Treatment and follow-up are recorded as 4 weeks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of treatment, endpoint measurement and follow-up times	Material needed: Relapse after 4 weeks, changes after stopping and durable clearance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich adults with symptomatic lesions are represented?Required	The population is adults with painful or burning erosive or ulcerative oral lichen planus. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Pain/burning and selection of erosive or ulcerative lesions	Material needed: Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat steroid treatment was common to both groups?Required	Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Common 0.1% triamcinolone rinse and the additional-gel comparison	Material needed: Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich denominators are represented by 31 people and 14 versus 17?Required	The retained sample size is 31 people: active 14 and placebo 17. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Allocation, analysis and completion counts and endpoint-specific denominators	Material needed: The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre 2 and 4 weeks kept within the same trial?Required	The same report gives adjusted REU differences at 2 and 4 weeks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Timepoint-specific results within the same paper and unique trial families	Material needed: The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat is the selected result at 4 weeks?Required	The retained adjusted difference at 4 weeks is −5.93 (SE 1.12), P<.001. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Baseline-adjusted between-group REU difference and direction at 4 weeks	Material needed: Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionHow does the 2-week result differ from the selected outcome?Required	The adjusted difference at 2 weeks is −4.77 (SE 0.83), P<.001. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of the supporting 2-week timepoint and selected 4-week result	Material needed: The 2-week result is not treated as independent replication of the 4-week result or as a separate trial; prespecified timepoint hierarchy remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre SEs kept distinct from 95% CIs?Required	The retained results give SE 0.83 at 2 weeks and SE 1.12 at 4 weeks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of standard errors and original confidence intervals	Material needed: Original 95% CIs remain unverified; new CIs are not calculated from SEs. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionDoes P<.001 establish a clinically important difference?Required	Both timepoints are retained as P<.001. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Statistical signals and criteria important to patients	Material needed: An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionIs the baseline-adjustment analysis specified?Required	The result is described as a baseline-adjusted between-group REU difference. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Baseline-adjustment model, covariates and analysis population	Material needed: Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat were the actual randomization procedures?Required	The design is named as a randomized double-blind placebo-gel add-on trial. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Sequence generation, allocation concealment and implementation	Material needed: Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre gel masking and REU-assessor blinding distinguished?Required	The retained design is described as double blind. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Gel distinguishability and participant/assessor blinding	Material needed: Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionHow was the REU assessment instrument applied?Required	The principal endpoint in the retained record is REU score at 4 weeks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Score range, assessment rules and assessor agreement	Material needed: Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionWas REU a prespecified primary endpoint?Required	The retained verdict selects REU as its main question. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Endpoint/timepoint hierarchy in registration, protocol and SAP	Material needed: Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionHow are multiple timepoints and outcomes addressed?Required	The stored summary notes the possibility of exaggeration with multiple timepoints/outcomes and a small sample. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Planned timepoints, number of outcomes, selective reporting and multiplicity	Material needed: Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionAre analyzed/completed counts and observation loss known?Required	The retained scale is 31 people, active 14/placebo 17. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Timepoint-specific losses, reasons and missing-data handling	Material needed: Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionIs pain VAS the same claim as REU?Required	The retained summary note separates pain VAS from this REU verdict. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separate presentation of lesion REU and pain VAS	Material needed: An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionDoes lesion-score change establish long-term clearance?Required	The stored summary describes REU as a surrogate and separates relapse and long-term lesion clearance. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of a surrogate lesion score, relapse and durable clearance	Material needed: The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionIs there independent replication with the same formulation?Required	The current stored summary retains 1 direct small-sample topical-trial report. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Same-gel add-on treatment and REU results from other independent teams	Material needed: The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre generic turmeric gel and oral curcumin kept separate?Required	The retained original record excludes extension to generic turmeric gel, swallowed curcumin and steroid replacement. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Directness for formulation, route and standard treatment	Material needed: Other products, monotherapy and direct between-formulation comparative effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionCan superiority of a dose or application duration be established?Required	The current question concerns 1%, application 3 times daily and 4 weeks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Direct concentration/frequency comparisons, subgroups and duration comparisons	Material needed: The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre the cited registration identifier and unverified registration kept distinct?Required	The bibliography retains IRCT20190523043678N1 while registration status in the original record remains unverified. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	IRCT bibliographic notation and actual registration/change history	Material needed: A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat is the scope of academic funding and declared no-conflict wording?Required	The record describes an academic study and reports a declaration of no conflicts. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original funding and declared conflict-of-interest statements	Material needed: Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre product support and employee authorship considered separately?Required	The original funding description states that detailed product roles remain unverified. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of funding, supplied products, company authors and declared conflicts	Material needed: Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionHow were topical harm events collected?Supplementary	The retained safety description says long-term mucosal irritation, allergy and absorption risks cannot be excluded. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Collection and definitions of mucosal irritation, allergy and absorption-related events	Material needed: Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre harm denominators and comparisons known?Supplementary	Only the scope of a small sample and 4 weeks of topical use is retained. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Exposed participants, affected people and follow-up time by group	Material needed: Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionDoes the record support stopping standard treatment or long-term safety?Supplementary	The retained original record does not support stopping standard treatment, and 4-week data cannot exclude long-term risks. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Common rinse, persistent/rare harms and application boundaries	Material needed: Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionDoes an English correction establish external reading?Required	The original stored record retains a correction to 1 placeholder field in the English evidence table. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Retained Korean/English records and the correction event dated 2026-09-14	Material needed: Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWere the original grade, axes and date changed?Required	The original verdict is C54 with Caution, and its original record date is 2026-09-08. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Preservation of C54, Caution, original axes and the original date 2026-09-08	Material needed: No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhat material has actually been acquired and read?Required	The full retained summary, including Korean/English content, axes, 1 report and 1 citation, was used for preparation. R01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separation of the stored summary from external abstract, full text, registration and planning material	Material needed: PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.

No items match your search or filter.

34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.
Population: The retained population is adults with painful or burning erosive or ulcerative oral lichen planus. Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified.
Ingredient, formulation and route: This is add-on topical application of 1% nanomicellar oral gel containing curcumin derived from Curcuma longa to oral lesions. Composition, active amount, micellar characteristics, excipients, stability and batch information remain unverified.
Dose: The recorded schedule is application 3 times daily. Amount per application, adherence and actual swallowing/absorption remain unverified; daily active amount is not calculated from concentration and frequency.
Comparator: Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel. Rinse schedule, adherence and balance of concurrent treatment remain unverified; this is not interpreted as a steroid-replacement trial.
Measured outcome: The selected question concerns the baseline-adjusted between-group difference in REU lesion score at 4 weeks. The same trial result at 2 weeks, pain VAS, relapse and long-term lesion clearance remain separate; prespecified primary-endpoint and timepoint hierarchies remain unverified.
Duration: Treatment and follow-up are recorded as 4 weeks. Subsequent relapse, changes after stopping, long-term lesion clearance and long-term/rare harms remain unverified.
Questions outside this scope: Generic turmeric gel, swallowed curcumin and other formulations/routes are not treated as interchangeable.; An add-on effect over common steroid rinse is not extended to monotherapy, steroid replacement or support for stopping standard treatment.; An REU lesion-score difference is not relabeled as pain relief, cure, relapse prevention, durable clearance or overall safety.; Standard errors, significance values and a small sample are not relabeled as verification of original confidence intervals or patient-important differences.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · 2020 · Oral lichen planus add-on trial of 1% nanocurcumin gel with common steroid rinse

PubMed

Material type: Stored summary of a randomized double-blind placebo-gel add-on trial; actual allocation, blinding and analysis details remain unverified
Materials actually read: Stored existing review summary read; external paper, abstract, full text, registration and planning material unread
Findings recorded in the stored summary: Adjusted differences: −4.77 (SE 0.83) at 2 weeks and −5.93 (SE 1.12) at 4 weeks, each P<.001
Record level: These are baseline-adjusted between-group differences in the stored summary. Actual analysis models, timepoint-specific denominators and original 95% CIs remain unverified. CIs are not newly calculated from SEs, and pain and long-term healing outcomes remain separate.
Study overlap and independent replication: The record retains 31 people, active 14/placebo 17, and results at 2 and 4 weeks linked to one trial report. Actual allocation/analysis/completion roles, endpoint denominators, independent replication, and unique-trial and participant totals remain separately unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	This is the stored summary actually read. It does not establish full-paper reading or verification of actual allocation/analysis/completion denominators. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.
External paper and abstract link	Original bibliography link only; external content unread	Unread; no access attempt	Unread	The original PubMed citation URL is linked. There is no record of reading the external page, abstract or full text. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.
External full paper	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original bibliography: Bakhshi M et al. Biomed Res Int. 2020;2020:4298193. PMID: 32518558. PMCID: PMC7256737. DOI: 10.1155/2020/4298193. The presence of identifiers remains distinct from full-text acquisition, download and reading. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	IRCT20190523043678N1 appears in the original bibliography, while registration remains unverified in the original record. Actual registration contents, prospective-registration status, change history and URL remain unverified. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.
Protocol and analysis plan	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Protocol, SAP, prespecified REU/timepoint hierarchy, multiplicity, models and missing-data plans remain unread. Existence, public availability and acquisition of separate material also remain unverified. This links the stored summary and original bibliography. Actual paper, registration and planning contents, study-family identity and independent replication remain separately unverified; bibliographic identifiers alone do not establish original-source reading. The timestamp retained for the stored summary records its preparation, not external reading. Dates for external material are unrecorded. The evidence date 2026-09-08 belongs to the original record and is distinct from current full-text reading, completed search or completed content review.

Report counts versus independent study counts

The record retains 31 people, active 14/placebo 17, and results at 2 and 4 weeks linked to one trial report. Actual allocation/analysis/completion roles, endpoint denominators, independent replication, and unique-trial and participant totals remain separately unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which topical add-on question is covered?

Required materials and conditions: The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus
Conditions for verification: Original records on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N02 · What is the 1% nanomicellar oral gel?

Required materials and conditions: Composition, nanomicelles, manufacture and active amount of the 1% formulation
Conditions for verification: Original records on Composition, nanomicelles, manufacture and active amount of the 1% formulation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Composition, nanomicelles, manufacture and active amount of the 1% formulation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N03 · Are swallowed formulations distinguished from topical application?

Required materials and conditions: Local application to lesions and the scope of swallowing/absorption
Conditions for verification: Original records on Local application to lesions and the scope of swallowing/absorption must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Local application to lesions and the scope of swallowing/absorption is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N04 · Does application 3 times daily specify the total active dose?

Required materials and conditions: Application frequency, amount per application and adherence
Conditions for verification: Original records on Application frequency, amount per application and adherence must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Application frequency, amount per application and adherence is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N05 · Does 4 weeks describe both treatment and follow-up?

Required materials and conditions: Separation of treatment, endpoint measurement and follow-up times
Conditions for verification: Original records on Separation of treatment, endpoint measurement and follow-up times must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of treatment, endpoint measurement and follow-up times is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N06 · Which adults with symptomatic lesions are represented?

Required materials and conditions: Pain/burning and selection of erosive or ulcerative lesions
Conditions for verification: Original records on Pain/burning and selection of erosive or ulcerative lesions must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Pain/burning and selection of erosive or ulcerative lesions is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N07 · What steroid treatment was common to both groups?

Required materials and conditions: Common 0.1% triamcinolone rinse and the additional-gel comparison
Conditions for verification: Original records on Common 0.1% triamcinolone rinse and the additional-gel comparison must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Common 0.1% triamcinolone rinse and the additional-gel comparison is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N08 · Which denominators are represented by 31 people and 14 versus 17?

Required materials and conditions: Allocation, analysis and completion counts and endpoint-specific denominators
Conditions for verification: Original records on Allocation, analysis and completion counts and endpoint-specific denominators must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Allocation, analysis and completion counts and endpoint-specific denominators is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N09 · Are 2 and 4 weeks kept within the same trial?

Required materials and conditions: Timepoint-specific results within the same paper and unique trial families
Conditions for verification: Original records on Timepoint-specific results within the same paper and unique trial families must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Timepoint-specific results within the same paper and unique trial families is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N10 · What is the selected result at 4 weeks?

Required materials and conditions: Baseline-adjusted between-group REU difference and direction at 4 weeks
Conditions for verification: Original records on Baseline-adjusted between-group REU difference and direction at 4 weeks must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Baseline-adjusted between-group REU difference and direction at 4 weeks is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N11 · How does the 2-week result differ from the selected outcome?

Required materials and conditions: Separation of the supporting 2-week timepoint and selected 4-week result
Conditions for verification: Original records on Separation of the supporting 2-week timepoint and selected 4-week result must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of the supporting 2-week timepoint and selected 4-week result is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N12 · Are SEs kept distinct from 95% CIs?

Required materials and conditions: Separation of standard errors and original confidence intervals
Conditions for verification: Original records on Separation of standard errors and original confidence intervals must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of standard errors and original confidence intervals is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N13 · Does P<.001 establish a clinically important difference?

Required materials and conditions: Statistical signals and criteria important to patients
Conditions for verification: Original records on Statistical signals and criteria important to patients must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Statistical signals and criteria important to patients is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N14 · Is the baseline-adjustment analysis specified?

Required materials and conditions: Baseline-adjustment model, covariates and analysis population
Conditions for verification: Original records on Baseline-adjustment model, covariates and analysis population must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Baseline-adjustment model, covariates and analysis population is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N15 · What were the actual randomization procedures?

Required materials and conditions: Sequence generation, allocation concealment and implementation
Conditions for verification: Original records on Sequence generation, allocation concealment and implementation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Sequence generation, allocation concealment and implementation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N16 · Are gel masking and REU-assessor blinding distinguished?

Required materials and conditions: Gel distinguishability and participant/assessor blinding
Conditions for verification: Original records on Gel distinguishability and participant/assessor blinding must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Gel distinguishability and participant/assessor blinding is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N17 · How was the REU assessment instrument applied?

Required materials and conditions: Score range, assessment rules and assessor agreement
Conditions for verification: Original records on Score range, assessment rules and assessor agreement must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Score range, assessment rules and assessor agreement is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N18 · Was REU a prespecified primary endpoint?

Required materials and conditions: Endpoint/timepoint hierarchy in registration, protocol and SAP
Conditions for verification: Original records on Endpoint/timepoint hierarchy in registration, protocol and SAP must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Endpoint/timepoint hierarchy in registration, protocol and SAP is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N19 · How are multiple timepoints and outcomes addressed?

Required materials and conditions: Planned timepoints, number of outcomes, selective reporting and multiplicity
Conditions for verification: Original records on Planned timepoints, number of outcomes, selective reporting and multiplicity must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Planned timepoints, number of outcomes, selective reporting and multiplicity is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N20 · Are analyzed/completed counts and observation loss known?

Required materials and conditions: Timepoint-specific losses, reasons and missing-data handling
Conditions for verification: Original records on Timepoint-specific losses, reasons and missing-data handling must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Timepoint-specific losses, reasons and missing-data handling is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N21 · Is pain VAS the same claim as REU?

Required materials and conditions: Separate presentation of lesion REU and pain VAS
Conditions for verification: Original records on Separate presentation of lesion REU and pain VAS must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separate presentation of lesion REU and pain VAS is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N22 · Does lesion-score change establish long-term clearance?

Required materials and conditions: Separation of a surrogate lesion score, relapse and durable clearance
Conditions for verification: Original records on Separation of a surrogate lesion score, relapse and durable clearance must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of a surrogate lesion score, relapse and durable clearance is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N23 · Is there independent replication with the same formulation?

Required materials and conditions: Same-gel add-on treatment and REU results from other independent teams
Conditions for verification: Original records on Same-gel add-on treatment and REU results from other independent teams must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Same-gel add-on treatment and REU results from other independent teams is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N24 · Are generic turmeric gel and oral curcumin kept separate?

Required materials and conditions: Directness for formulation, route and standard treatment
Conditions for verification: Original records on Directness for formulation, route and standard treatment must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Directness for formulation, route and standard treatment is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N25 · Can superiority of a dose or application duration be established?

Required materials and conditions: Direct concentration/frequency comparisons, subgroups and duration comparisons
Conditions for verification: Original records on Direct concentration/frequency comparisons, subgroups and duration comparisons must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Direct concentration/frequency comparisons, subgroups and duration comparisons is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N26 · Are the cited registration identifier and unverified registration kept distinct?

Required materials and conditions: IRCT bibliographic notation and actual registration/change history
Conditions for verification: Original records on IRCT bibliographic notation and actual registration/change history must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on IRCT bibliographic notation and actual registration/change history is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N27 · What is the scope of academic funding and declared no-conflict wording?

Required materials and conditions: Original funding and declared conflict-of-interest statements
Conditions for verification: Original records on Original funding and declared conflict-of-interest statements must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Original funding and declared conflict-of-interest statements is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N28 · Are product support and employee authorship considered separately?

Required materials and conditions: Separation of funding, supplied products, company authors and declared conflicts
Conditions for verification: Original records on Separation of funding, supplied products, company authors and declared conflicts must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of funding, supplied products, company authors and declared conflicts is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N29 · How were topical harm events collected?

Required materials and conditions: Collection and definitions of mucosal irritation, allergy and absorption-related events
Conditions for verification: Original records on Collection and definitions of mucosal irritation, allergy and absorption-related events must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Collection and definitions of mucosal irritation, allergy and absorption-related events is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N30 · Are harm denominators and comparisons known?

Required materials and conditions: Exposed participants, affected people and follow-up time by group
Conditions for verification: Original records on Exposed participants, affected people and follow-up time by group must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Exposed participants, affected people and follow-up time by group is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N31 · Does the record support stopping standard treatment or long-term safety?

Required materials and conditions: Common rinse, persistent/rare harms and application boundaries
Conditions for verification: Original records on Common rinse, persistent/rare harms and application boundaries must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Common rinse, persistent/rare harms and application boundaries is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N32 · Does an English correction establish external reading?

Required materials and conditions: Retained Korean/English records and the correction event dated 2026-09-14
Conditions for verification: Original records on Retained Korean/English records and the correction event dated 2026-09-14 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Retained Korean/English records and the correction event dated 2026-09-14 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N33 · Were the original grade, axes and date changed?

Required materials and conditions: Preservation of C54, Caution, original axes and the original date 2026-09-08
Conditions for verification: Original records on Preservation of C54, Caution, original axes and the original date 2026-09-08 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Preservation of C54, Caution, original axes and the original date 2026-09-08 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

N34 · What material has actually been acquired and read?

Required materials and conditions: Separation of the stored summary from external abstract, full text, registration and planning material
Conditions for verification: Original records on Separation of the stored summary from external abstract, full text, registration and planning material must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Why this condition is needed: Material on Separation of the stored summary from external abstract, full text, registration and planning material is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete: Review of existing content remains incomplete.
Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable: Used only with an application exception and reason based on the question scope.
Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which topical add-on question is covered?

Current findings: The original question concerns improvement of REU lesion scores in symptomatic oral lichen planus.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Curcumin monotherapy and steroid replacement are outside this comparison.
Required materials and conditions: The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus
Materials to obtain first: Curcumin monotherapy and steroid replacement are outside this comparison. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Curcumin monotherapy and steroid replacement are outside this comparison. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The placebo-gel add-on comparison for REU at 4 weeks in symptomatic oral lichen planus is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N02 · What is the 1% nanomicellar oral gel?

Current findings: The intervention is a 1% oral gel containing nanomicellar curcumin derived from Curcuma longa.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified.
Required materials and conditions: Composition, nanomicelles, manufacture and active amount of the 1% formulation
Materials to obtain first: Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Product quantification, particle/micellar characteristics, excipients, stability and batch information remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Composition, nanomicelles, manufacture and active amount of the 1% formulation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Composition, nanomicelles, manufacture and active amount of the 1% formulation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N03 · Are swallowed formulations distinguished from topical application?

Current findings: The route is topical application to oral lesions.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified.
Required materials and conditions: Local application to lesions and the scope of swallowing/absorption
Materials to obtain first: This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: This is not interchangeable with swallowed curcumin; actual application amount, swallowing and absorption remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Local application to lesions and the scope of swallowing/absorption must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Local application to lesions and the scope of swallowing/absorption is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N04 · Does application 3 times daily specify the total active dose?

Current findings: The recorded schedule is application 3 times daily.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Daily mg, amount per application and absorbed amount are not calculated from 1% concentration and application 3 times daily. Application amount and adherence remain unverified.
Required materials and conditions: Application frequency, amount per application and adherence
Materials to obtain first: Daily mg, amount per application and absorbed amount are not calculated from 1% concentration and application 3 times daily. Application amount and adherence remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Daily mg, amount per application and absorbed amount are not calculated from 1% concentration and application 3 times daily. Application amount and adherence remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Application frequency, amount per application and adherence must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Application frequency, amount per application and adherence is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N05 · Does 4 weeks describe both treatment and follow-up?

Current findings: Treatment and follow-up are recorded as 4 weeks.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Relapse after 4 weeks, changes after stopping and durable clearance remain unverified.
Required materials and conditions: Separation of treatment, endpoint measurement and follow-up times
Materials to obtain first: Relapse after 4 weeks, changes after stopping and durable clearance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Relapse after 4 weeks, changes after stopping and durable clearance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of treatment, endpoint measurement and follow-up times must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of treatment, endpoint measurement and follow-up times is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N06 · Which adults with symptomatic lesions are represented?

Current findings: The population is adults with painful or burning erosive or ulcerative oral lichen planus.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified.
Required materials and conditions: Pain/burning and selection of erosive or ulcerative lesions
Materials to obtain first: Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Diagnosis, histological confirmation, disease duration, severity and detailed eligibility/exclusion criteria remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Pain/burning and selection of erosive or ulcerative lesions must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Pain/burning and selection of erosive or ulcerative lesions is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N07 · What steroid treatment was common to both groups?

Current findings: Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified.
Required materials and conditions: Common 0.1% triamcinolone rinse and the additional-gel comparison
Materials to obtain first: Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Rinse frequency, medication adherence and balance of concurrent treatment remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Common 0.1% triamcinolone rinse and the additional-gel comparison must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Common 0.1% triamcinolone rinse and the additional-gel comparison is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N08 · Which denominators are represented by 31 people and 14 versus 17?

Current findings: The retained sample size is 31 people: active 14 and placebo 17.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed.
Required materials and conditions: Allocation, analysis and completion counts and endpoint-specific denominators
Materials to obtain first: The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The allocation/analysis/completion role of each count and actual REU denominators at each timepoint remain unverified. No additional calculation is performed. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Allocation, analysis and completion counts and endpoint-specific denominators must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Allocation, analysis and completion counts and endpoint-specific denominators is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N09 · Are 2 and 4 weeks kept within the same trial?

Current findings: The same report gives adjusted REU differences at 2 and 4 weeks.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants.
Required materials and conditions: Timepoint-specific results within the same paper and unique trial families
Materials to obtain first: The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The 2 timepoints and multiple bibliographic identifiers are not added as independent trials or repeated participants. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Timepoint-specific results within the same paper and unique trial families must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Timepoint-specific results within the same paper and unique trial families is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N10 · What is the selected result at 4 weeks?

Current findings: The retained adjusted difference at 4 weeks is −5.93 (SE 1.12), P<.001.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified.
Required materials and conditions: Baseline-adjusted between-group REU difference and direction at 4 weeks
Materials to obtain first: Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Original 95% CIs, timepoint-specific analysis denominators and baseline details remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Baseline-adjusted between-group REU difference and direction at 4 weeks must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Baseline-adjusted between-group REU difference and direction at 4 weeks is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N11 · How does the 2-week result differ from the selected outcome?

Current findings: The adjusted difference at 2 weeks is −4.77 (SE 0.83), P<.001.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The 2-week result is not treated as independent replication of the 4-week result or as a separate trial; prespecified timepoint hierarchy remains unverified.
Required materials and conditions: Separation of the supporting 2-week timepoint and selected 4-week result
Materials to obtain first: The 2-week result is not treated as independent replication of the 4-week result or as a separate trial; prespecified timepoint hierarchy remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The 2-week result is not treated as independent replication of the 4-week result or as a separate trial; prespecified timepoint hierarchy remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of the supporting 2-week timepoint and selected 4-week result must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of the supporting 2-week timepoint and selected 4-week result is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N12 · Are SEs kept distinct from 95% CIs?

Current findings: The retained results give SE 0.83 at 2 weeks and SE 1.12 at 4 weeks.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original 95% CIs remain unverified; new CIs are not calculated from SEs.
Required materials and conditions: Separation of standard errors and original confidence intervals
Materials to obtain first: Original 95% CIs remain unverified; new CIs are not calculated from SEs. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Original 95% CIs remain unverified; new CIs are not calculated from SEs. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of standard errors and original confidence intervals must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of standard errors and original confidence intervals is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N13 · Does P<.001 establish a clinically important difference?

Current findings: Both timepoints are retained as P<.001.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified.
Required materials and conditions: Statistical signals and criteria important to patients
Materials to obtain first: An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: An important-difference threshold for REU, perceived symptom benefit and durable healing remain separately unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Statistical signals and criteria important to patients must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Statistical signals and criteria important to patients is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N14 · Is the baseline-adjustment analysis specified?

Current findings: The result is described as a baseline-adjusted between-group REU difference.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified.
Required materials and conditions: Baseline-adjustment model, covariates and analysis population
Materials to obtain first: Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Model type, covariates, baseline group differences, ITT/adherent-participant analyses and repeated-measure handling remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Baseline-adjustment model, covariates and analysis population must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Baseline-adjustment model, covariates and analysis population is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N15 · What were the actual randomization procedures?

Current findings: The design is named as a randomized double-blind placebo-gel add-on trial.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified.
Required materials and conditions: Sequence generation, allocation concealment and implementation
Materials to obtain first: Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Allocation sequence, concealment, implementation responsibilities and baseline balance remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Sequence generation, allocation concealment and implementation must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Sequence generation, allocation concealment and implementation is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N16 · Are gel masking and REU-assessor blinding distinguished?

Current findings: The retained design is described as double blind.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified.
Required materials and conditions: Gel distinguishability and participant/assessor blinding
Materials to obtain first: Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Whether gels could be distinguished by color, taste or formulation, assessor blinding and blinding success remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Gel distinguishability and participant/assessor blinding must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Gel distinguishability and participant/assessor blinding is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N17 · How was the REU assessment instrument applied?

Current findings: The principal endpoint in the retained record is REU score at 4 weeks.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified.
Required materials and conditions: Score range, assessment rules and assessor agreement
Materials to obtain first: Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Instrument application, assessor training, score range, reproducibility and a clinically important-difference threshold remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Score range, assessment rules and assessor agreement must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Score range, assessment rules and assessor agreement is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N18 · Was REU a prespecified primary endpoint?

Current findings: The retained verdict selects REU as its main question.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified.
Required materials and conditions: Endpoint/timepoint hierarchy in registration, protocol and SAP
Materials to obtain first: Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Original registration, protocol and SAP are unread, so the prespecified primary endpoint and multiple-analysis plan remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Endpoint/timepoint hierarchy in registration, protocol and SAP must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Endpoint/timepoint hierarchy in registration, protocol and SAP is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N19 · How are multiple timepoints and outcomes addressed?

Current findings: The stored summary notes the possibility of exaggeration with multiple timepoints/outcomes and a small sample.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified.
Required materials and conditions: Planned timepoints, number of outcomes, selective reporting and multiplicity
Materials to obtain first: Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Multiplicity adjustment, all planned outcomes and omitted reporting remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Planned timepoints, number of outcomes, selective reporting and multiplicity must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Planned timepoints, number of outcomes, selective reporting and multiplicity is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N20 · Are analyzed/completed counts and observation loss known?

Current findings: The retained scale is 31 people, active 14/placebo 17.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified.
Required materials and conditions: Timepoint-specific losses, reasons and missing-data handling
Materials to obtain first: Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Endpoint-specific analyzed counts, withdrawals, adherence and missing-data imputation remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Timepoint-specific losses, reasons and missing-data handling must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Timepoint-specific losses, reasons and missing-data handling is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N21 · Is pain VAS the same claim as REU?

Current findings: The retained summary note separates pain VAS from this REU verdict.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified.
Required materials and conditions: Separate presentation of lesion REU and pain VAS
Materials to obtain first: An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: An REU difference is not substituted for the magnitude of pain improvement; the separate exact pain effect remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separate presentation of lesion REU and pain VAS must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separate presentation of lesion REU and pain VAS is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N22 · Does lesion-score change establish long-term clearance?

Current findings: The stored summary describes REU as a surrogate and separates relapse and long-term lesion clearance.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention.
Required materials and conditions: Separation of a surrogate lesion score, relapse and durable clearance
Materials to obtain first: The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The score at 4 weeks is not extended to cure, long-term lesion clearance or relapse prevention. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of a surrogate lesion score, relapse and durable clearance must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of a surrogate lesion score, relapse and durable clearance is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N23 · Is there independent replication with the same formulation?

Current findings: The current stored summary retains 1 direct small-sample topical-trial report.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified.
Required materials and conditions: Same-gel add-on treatment and REU results from other independent teams
Materials to obtain first: The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The presence of 1 report does not establish that only 1 trial exists worldwide; same-formulation independent replication and unique-participant totals remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Same-gel add-on treatment and REU results from other independent teams must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Same-gel add-on treatment and REU results from other independent teams is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N24 · Are generic turmeric gel and oral curcumin kept separate?

Current findings: The retained original record excludes extension to generic turmeric gel, swallowed curcumin and steroid replacement.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Other products, monotherapy and direct between-formulation comparative effects remain unverified.
Required materials and conditions: Directness for formulation, route and standard treatment
Materials to obtain first: Other products, monotherapy and direct between-formulation comparative effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Other products, monotherapy and direct between-formulation comparative effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Directness for formulation, route and standard treatment must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Directness for formulation, route and standard treatment is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N25 · Can superiority of a dose or application duration be established?

Current findings: The current question concerns 1%, application 3 times daily and 4 weeks.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage.
Required materials and conditions: Direct concentration/frequency comparisons, subgroups and duration comparisons
Materials to obtain first: The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: The stored summary does not verify direct comparisons establishing an optimal concentration, frequency, duration or subgroup advantage. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Direct concentration/frequency comparisons, subgroups and duration comparisons must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Direct concentration/frequency comparisons, subgroups and duration comparisons is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N26 · Are the cited registration identifier and unverified registration kept distinct?

Current findings: The bibliography retains IRCT20190523043678N1 while registration status in the original record remains unverified.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate.
Required materials and conditions: IRCT bibliographic notation and actual registration/change history
Materials to obtain first: A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: A bibliographic identifier does not establish actual registration reading or prospective-registration verification. Different levels of recorded information remain separate. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on IRCT bibliographic notation and actual registration/change history must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on IRCT bibliographic notation and actual registration/change history is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N27 · What is the scope of academic funding and declared no-conflict wording?

Current findings: The record describes an academic study and reports a declaration of no conflicts.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified.
Required materials and conditions: Original funding and declared conflict-of-interest statements
Materials to obtain first: Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Supporting institutions, amounts, original declarations and detailed investigator relationships remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Original funding and declared conflict-of-interest statements must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Original funding and declared conflict-of-interest statements is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N28 · Are product support and employee authorship considered separately?

Current findings: The original funding description states that detailed product roles remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration.
Required materials and conditions: Separation of funding, supplied products, company authors and declared conflicts
Materials to obtain first: Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Product supply, manufacturer roles and employee authorship remain separately unverified despite the reported no-conflict declaration. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of funding, supplied products, company authors and declared conflicts must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of funding, supplied products, company authors and declared conflicts is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N29 · How were topical harm events collected?

Current findings: The retained safety description says long-term mucosal irritation, allergy and absorption risks cannot be excluded.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified.
Required materials and conditions: Collection and definitions of mucosal irritation, allergy and absorption-related events
Materials to obtain first: Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Actual collection methods, severity, discontinuations, temporal ordering and original-report classifications remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Collection and definitions of mucosal irritation, allergy and absorption-related events must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Collection and definitions of mucosal irritation, allergy and absorption-related events is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N30 · Are harm denominators and comparisons known?

Current findings: Only the scope of a small sample and 4 weeks of topical use is retained.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established.
Required materials and conditions: Exposed participants, affected people and follow-up time by group
Materials to obtain first: Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Without event denominators, event counts, risk differences and exposure time, absence of rare harms or safety equivalence is not established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Exposed participants, affected people and follow-up time by group must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Exposed participants, affected people and follow-up time by group is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N31 · Does the record support stopping standard treatment or long-term safety?

Current findings: The retained original record does not support stopping standard treatment, and 4-week data cannot exclude long-term risks.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified.
Required materials and conditions: Common rinse, persistent/rare harms and application boundaries
Materials to obtain first: Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Attribution of events involving common steroid treatment and long-term/vulnerable-group harms remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Common rinse, persistent/rare harms and application boundaries must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Common rinse, persistent/rare harms and application boundaries is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N32 · Does an English correction establish external reading?

Current findings: The original stored record retains a correction to 1 placeholder field in the English evidence table.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete.
Required materials and conditions: Retained Korean/English records and the correction event dated 2026-09-14
Materials to obtain first: Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: Generic English evidence wording differs from original-paper verification; comparison of the correction with original wording remains incomplete. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Retained Korean/English records and the correction event dated 2026-09-14 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Retained Korean/English records and the correction event dated 2026-09-14 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N33 · Were the original grade, axes and date changed?

Current findings: The original verdict is C54 with Caution, and its original record date is 2026-09-08.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date.
Required materials and conditions: Preservation of C54, Caution, original axes and the original date 2026-09-08
Materials to obtain first: No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: No new score, grade, official assessment or independent clinical certification is produced. This date is not read as a completed-search date. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Preservation of C54, Caution, original axes and the original date 2026-09-08 must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Preservation of C54, Caution, original axes and the original date 2026-09-08 is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01

N34 · What material has actually been acquired and read?

Current findings: The full retained summary, including Korean/English content, axes, 1 report and 1 citation, was used for preparation.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread.
Required materials and conditions: Separation of the stored summary from external abstract, full text, registration and planning material
Materials to obtain first: PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately.
Further research: Material needed: PubMed, PMCID and IRCT bibliographic entries do not establish current external reading. External abstract, full text, registration, protocol and SAP all remain unread. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in actual composition, application amount, common treatment, allocation/blinding, score assessment, prespecified plans, analysis denominators, confidence intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
Conditions for verification: Original records on Separation of the stored summary from external abstract, full text, registration and planning material must link to formulation, application, common treatment, population, placebo comparison, REU, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separation of the stored summary from external abstract, full text, registration and planning material is needed to connect the relevant topical gel, population, common treatment, add-on comparison, selected REU result, analysis denominator or harm scope.
Application exceptions: Add-on therapy is not relabeled as monotherapy or steroid replacement; lesion scores remain distinct from pain, relapse and durable clearance. Active dose is not calculated from concentration and application frequency, and confidence intervals are not newly derived from standard errors. Reported sample size also remains distinct from actual analysis and harm denominators.
Referenced methods: Existing principles distinguish formulation, topical route, common steroid treatment, placebo gel, REU lesion scores, timepoints, analysis denominators, uncertainty, support and harms in the retained oral-gel add-on record.

Related sources R01