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

Verdict 3044 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-25

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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.

## Checklist items

### N01 · Which topical add-on question is covered?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original question concerns improvement of REU lesion scores in symptomatic oral lichen planus.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The intervention is a 1% oral gel containing nanomicellar curcumin derived from Curcuma longa.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The route is topical application to oral lesions.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The recorded schedule is application 3 times daily.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Treatment and follow-up are recorded as 4 weeks.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The population is adults with painful or burning erosive or ulcerative oral lichen planus.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Both groups used 0.1% triamcinolone rinse while active gel was compared with placebo gel.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained sample size is 31 people: active 14 and placebo 17.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The same report gives adjusted REU differences at 2 and 4 weeks.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained adjusted difference at 4 weeks is −5.93 (SE 1.12), P<.001.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The adjusted difference at 2 weeks is −4.77 (SE 0.83), P<.001.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained results give SE 0.83 at 2 weeks and SE 1.12 at 4 weeks.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Both timepoints are retained as P<.001.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The result is described as a baseline-adjusted between-group REU difference.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The design is named as a randomized double-blind placebo-gel add-on trial.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained design is described as double blind.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The principal endpoint in the retained record is REU score at 4 weeks.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained verdict selects REU as its main question.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The stored summary notes the possibility of exaggeration with multiple timepoints/outcomes and a small sample.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained scale is 31 people, active 14/placebo 17.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained summary note separates pain VAS from this REU verdict.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The stored summary describes REU as a surrogate and separates relapse and long-term lesion clearance.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The current stored summary retains 1 direct small-sample topical-trial report.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained original record excludes extension to generic turmeric gel, swallowed curcumin and steroid replacement.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The current question concerns 1%, application 3 times daily and 4 weeks.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The bibliography retains IRCT20190523043678N1 while registration status in the original record remains unverified.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The record describes an academic study and reports a declaration of no conflicts.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original funding description states that detailed product roles remain unverified.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained safety description says long-term mucosal irritation, allergy and absorption risks cannot be excluded.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Only the scope of a small sample and 4 weeks of topical use is retained.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained original record does not support stopping standard treatment, and 4-week data cannot exclude long-term risks.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original stored record retains a correction to 1 placeholder field in the English evidence table.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original verdict is C54 with Caution, and its original record date is 2026-09-08.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The full retained summary, including Korean/English content, axes, 1 report and 1 citation, was used for preparation.
- 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.
- 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.
- 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.
- 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

## Evidence and sources

### R01

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

[PubMed](https://pubmed.ncbi.nlm.nih.gov/32518558/)

Materials actually read: Stored existing review summary read; external paper, abstract, full text, registration and planning material unread  
Findings recorded in the 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.  
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.

| 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.
