Topical preparation from a 96%-ethanol extract of Nigella sativa seed × Reduced VASI and improved repigmentation in vitiligo

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich vitiligo/VASI question is addressed?Required	The original claim concerns reduced VASI and improved repigmentation in vitiligo. Its scope is an active-control comparison of topical ethanolic seed extract. S01	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.	Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation	Material needed: Specifications of formulation, population, comparator and endpoint. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWho participated and what were the baseline vitiligo characteristics?Required	The retained use conditions describe 52 participants/adults with vitiligo. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution	Material needed: Eligibility, baseline-characteristic and lesion-distribution material. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionDoes the oil terminology identify the actual formulation?Required	The retained manuscript describes the article's oil preparation as a 96% ethanolic seed extract, rather than simply pressed oil. S01	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.	Ground-seed extraction with 96% ethanol, followed by solvent evaporation	Material needed: Extraction, final-composition, batch and quantification material. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre other Nigella formulations and routes distinguished?Required	The selected route is topical skin application. The original restricts interchangeability among other Nigella formulations, purified constituents and combinations. S01	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.	Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations	Material needed: Direct comparison material separated by formulation and route. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionDoes the 100 g container specify the dose for 1 application?Required	The retained dose description is 2 applications to lesions daily; 100 g is the container quantity, and the dose for 1 application is unverified. S01	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.	2 daily applications, the 100 g container quantity and actual use	Material needed: Application, area, use-quantity and adherence records. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow are 6 months and monthly measurements distinguished?Required	The retained duration is 6 months, with VASI described as monthly repeated measurement. S01	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.	6 months of treatment/follow-up and monthly VASI measurement	Material needed: Monthly measurement and follow-up schedules. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionIs fish oil a placebo?Required	The retained comparator is topical fish oil, an active comparator. Within-group changes in both arms are not converted into a placebo-controlled effect. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Composition, administration and meaning of the topical fish-oil active comparison	Material needed: Fish-oil, administration and shared-care specifications. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionDoes this comparison answer phototherapy add-on or treatment-replacement questions?Required	The original distinguishes this preparation from pure oil, creams and standard-phototherapy combinations. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The selected active comparison versus phototherapy/standard-treatment combinations	Material needed: Concomitant-treatment, phototherapy and rescue-treatment material. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow is the direct report identified?Required	The retained bibliography records the 2014 report, PMID 25068060, PMCID PMC4102993 and DOI 10.5812/ircmj.4515. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI	Material needed: The direct original article and bibliographic record. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionDoes an IRCT number verify prospective registration?Required	The retained evidence-table registration field and bibliography record IRCT201201025069N5. The identifier is not promoted to actual registration reading. S01	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.	IRCT201201025069N5 and registration content, timing and history	Material needed: Registration content, protocol and amendment history. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWhat are the VASI endpoint and prospective testing hierarchy?Required	The original marks the exact 6-month between-group effect, 95% CI and prospective testing hierarchy as unverified. S01	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.	Prospective hierarchy of VASI change, monthly timepoints and body-site results	Material needed: Registration, protocol and SAP. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow were randomization and concealment performed?Required	The retained design description is a randomized, double-blind, active-controlled trial. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Allocation sequence, concealment and arm-specific recruitment flow	Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWere formulation-specific masking and assessor measurement maintained?Required	The report is retained as describing double blinding. S01	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.	Topical-preparation appearance/scent, participant/assessor masking and unmasking	Material needed: Preparation, masking and assessment methods. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhich denominators are described by 52 participants and no dropouts?Required	The retained sample description is 52 participants with no dropouts. Participant and lesion counts are not interchanged. S01	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.	Participants, arm-specific allocation, analysis, completion and lesion units	Material needed: Arm-specific flow, endpoint denominators and lesion-analysis material. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat are the missing-data rules and repeated-measures model assumptions?Required	The original describes repeated-measures analysis as reporting differences at months 4–6. S01	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.	Monthly repeated measurement, missingness, ITT, clustering and adjusted models	Material needed: SAP, repeated-measures and missing-data analysis material. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionHow is VASI calculated and interpreted?Required	The selected endpoint is VASI change, recorded as monthly repeated measurement. S01	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.	VASI calculation, baseline body sites, assessors and repigmentation interpretation	Material needed: VASI methods, baseline lesions and assessment material. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat are the before/after VASI values in each arm?Required	The retained result is 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36. Order and values are retained. S01	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.	Nigella/fish-oil means and variation values with arm correspondence	Material needed: Original arm-specific VASI tables, denominators and analysis definitions. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhich test does P<.020 at months 4–6 refer to?Required	The retained result is between-group P<.020 at months 4–6. The original describes reported differences from month 4 onward. S01	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.	Monthly between-group results, prospective testing and exact timepoints	Material needed: Monthly repeated measurement, between-group tests and SAP. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionIs the exact 6-month between-group effect and interval available?Required	The original marks the exact 6-month between-group effect and 95% CI as unverified. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The 6-month between-group estimate, 95% CI and effect type	Material needed: The 6-month between-group estimate, 95% CI and model output. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWas multiplicity across body sites and timepoints addressed?Required	The original records multiplicity concerns across body-site tests and timepoints. S01	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.	Body-site/monthly tests, multiplicity and selective reporting	Material needed: Results for all body sites/timepoints and SAP. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionDoes repigmentation establish an effect at every body site?Required	The original states that complete repigmentation and efficacy at every body site were not established. S01	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.	VASI, body-site effects, complete repigmentation and responders	Material needed: Body-site, responder and repigmentation results. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionIs the 33-person/47-lesion follow-up narrative independent confirmation?Required	The original supplementary summary describes the 33-person/47-lesion follow-up as uncontrolled and from the same team, and did not count it as independent confirmation. The current bibliography identifies the direct trial, rather than linking the follow-up report. S01	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.	33 participants, 47 lesions, uncontrolled design and same-team follow-up	Material needed: Follow-up bibliography, participant/lesion and cohort-linkage material. This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWhat are the unique-trial/participant and independent-replication counts?Required	The direct active-control report remains distinct from the narrative follow-up reference. The 52 participants, 33 participants and 47 lesions are not newly summed into participant totals or independent replication. S01	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.	Connections among the direct trial, narrative follow-up reference and multiple results	Material needed: A report–trial–cohort–lesion linkage table. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionDoes no specific funding mean independent funding?Required	The retained funding description reports no specific research funding; the original restricts claims of independently funded strengths as unverified. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The no-specific-research-funding statement versus actual funding and roles	Material needed: Research-funding, role and cost disclosures. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionDoes a Giah Essence preparation establish product support or employee authorship?Required	The retained funding record names a Giah Essence Phytopharm preparation. A manufacturer name does not replace separate verification of support, employee authorship or conflicts. S01	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.	Manufacturer, product provision, author employment and conflicts	Material needed: Original product-support, author-affiliation and conflict disclosures. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionHow were topical adverse events collected?Supplementary	The original states that small trials cannot exclude rare adverse events or establish long-term safety. S01	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.	Skin reactions, event definitions, arm-specific collection and exposure denominators	Material needed: Skin-event, collection and exposure-denominator material. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre extraction methods, product composition and safety interchangeable?Supplementary	The original states that constituent quantities can vary by product and extraction method. S01	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.	Product, extraction, constituent quantities and skin-exposure differences	Material needed: Formulation, constituent-quantity, exposure and safety material. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionAre vulnerable groups, concomitant medicines and longer-term harms answered?Supplementary	The retained safety wording records precautions for the relevant vulnerable-group/concomitant-medicine situations and limitations of long-term safety evidence. S01	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.	Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use	Material needed: Vulnerable-group, concomitant-medicine and longer-term harm material. This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionCan this be extended to standard-treatment replacement, pure oil or creams?Required	The original restricts standard-treatment replacement, pure oil, creams and phototherapy combinations as different questions. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	The selected ethanolic topical extract versus other products and treatment replacement	Material needed: Direct comparisons of replacement, combinations and other formulations. This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat are the current Korean/English wording and English correction?Required	The current Korean/English wording and the 1-field English correction on 2026-09-14 are retained. Generic English verification wording is not inherited as current quantitative or original-source verification. S01	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.	Current Korean/English wording, the 1-field correction and generic English evidence wording	Material needed: Before/after correction and language-correspondence material. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat are the original C/46, axes and historical cross-checking?Required	C/46, all original axes and historical cross-check wording are preserved as historical values. Uncertainty is not regraded as no effect or inherited as newly completed content review. S01	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.	C/46, EX/CX, all original axes and historical cross-checking	Material needed: Feedback and future correction material. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the dates, empty records and actual reading scope?Required	The retained original material was used for preparation. The original evidence date 2026-09-08, correction date 2026-09-14, empty subsidiary-claim records and empty additional discussion are retained. S01	Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original evidence/correction dates, empty original values and stored-summary/external-unread scope	Material needed: Needed original material and extraction/denominator/timepoint material when supplied. This records needed materials; no new research was executed.

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
Population: The retained record describes 52 participants/adults with vitiligo. Diagnosis, type, activity, baseline lesions, eligibility/exclusions and arm-specific randomized/analysis denominators remain incompletely verified. Participants and lesion counts remain distinct.
Ingredient, formulation and route: The topical preparation used ground Nigella sativa L. seeds extracted with 96% ethanol, followed by solvent evaporation. The article's oil terminology is not made interchangeable with simply pressed oil, pure fixed oil, creams, oral preparations, purified thymoquinone or combinations. Final composition, residual solvent, batches and quantification remain unverified.
Dose: The original record describes 2 applications to lesions daily. The 100 g quantity describes the container; the dose for 1 application, per-area amount, actual use, cumulative exposure and adherence remain unverified. Container quantity is not converted into a daily or recommended dose.
Comparator: The comparator is topical fish oil, an active comparator rather than placebo. Composition, application, shared care, sensory matching and concomitant standard treatment/changes remain unverified. Within-group changes do not establish a placebo-controlled effect or replacement of standard treatment.
Measured outcome: The endpoint is VASI change with monthly repeated measurement. Scale calculation, body-site contributions, assessor reliability, prospective principal endpoint/timepoint, multiplicity, patient importance, responders and complete repigmentation remain separately unverified.
Duration: The original record describes 6 months of treatment/follow-up. Detailed monthly schedules, persistence after treatment, relapse and longer follow-up remain unverified. The duration is not converted into another period or presented as establishing persistent effects.
Questions outside this scope: The selected question compares topical ethanolic seed extract with active fish oil for VASI/repigmentation in vitiligo. Other formulations, routes, placebo comparisons, phototherapy combinations and standard-treatment replacement are different questions.; The original C/46/Caution and B/P/R1/I1/EX/B2/CX are retained. Uncertainty is not converted into absence of effects, and historical cross-checking is not presented as current content review, formal-method execution or independent clinical validation.; The 96% value describes the ethanol used for seed extraction, with solvent evaporation recorded in the original. The 2 daily applications and 100 g container are retained; application, cumulative, daily and recommended doses are not newly calculated.; The original VASI values, 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36, are retained. The definition of ± and arm-specific analysis denominators remain unverified. Changes, between-group differences, percentages and effect intervals are not newly calculated.; The retained between-group P<.020 at months 4–6 is not converted into an exact 6-month effect, 95% CI or prospective testing hierarchy. Monthly/site-specific results remain distinct from complete/every-site repigmentation, responders and clinical importance.; The 52 participants and no-dropout statement are retained original descriptions. Arm-specific randomization, analysis, lesion units, missingness and harm denominators remain unverified. The later 33-person/47-lesion uncontrolled, same-team narrative is unlinked to the original bibliography and is not made into a new report, independent replication or participant total.; PMID25068060, PMCID PMC4102993, DOI10.5812/ircmj.4515 and IRCT201201025069N5 are identifiers in the existing bibliography. The registration number is not promoted to actual registration reading or verified prespecification; articles, plans and support disclosures remain unread.; The original evidence date 2026-09-08, correction of 1 English-placeholder field on 2026-09-14 and production date 2026-10-06 remain distinct. Generic English verification/funding wording and precautions are not inherited as current original-source reading, independence, harm collection or overall-safety certification.

Evidence and sources

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

S01 · 2014 · Topical Nigella preparation versus fish oil in vitiligo: active-control trial

PubMed

Material type: Stored description of a randomized, double-blind, active-controlled trial; actual allocation and masking procedures remain externally unverified
Materials actually read: Stored summary read; external material unread
Findings recorded in the stored summary: 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36; between-group P<.020 at months 4–6
Record level: These are existing reported values. The 52 participants/no-dropout description remains distinct from arm-specific analysis, lesion and harm denominators. Gaps remain in the definition of ±, the exact 6-month between-group effect/interval and prospective testing hierarchy. Original external material remains unread here.
Study overlap and independent replication: The direct active-control report remains distinct from a follow-up narrative unlinked to a separate bibliography. Reports, trials, teams, participants and lesions are not substituted for or added to one another; unique-trial, participant and independent-replication counts remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	Only the stored summary/bibliography was read for preparation. This is not full-text acquisition/reading or clinical validation. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
External article material	Original bibliography link only; external content unread	Unread; no access attempt	Unread	The original PubMed link and PMCID PMC4102993 are retained as identifiers. Acquisition, public availability, successful access and actual reading of external articles, abstracts and full texts were not verified here. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	IRCT201201025069N5 is the registration identifier in the original bibliography. Registration content, timing, amendments and endpoint correspondence were not read, and prospective registration was not certified. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
Protocol	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The protocol is unread. Original plans, principal endpoints, timepoints, comparisons and amendment histories were not verified. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
Statistical analysis plan	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Analysis plans are unread. Repeated measurement, lesion structure, missingness, multiplicity and exact between-group effects/intervals were not verified or reverse-calculated. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.
Funding, product-support and conflict material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The retained descriptions of no specific research funding and a Giah Essence Phytopharm preparation are preserved. Funding, product-support, employee-authorship and conflict disclosures remain separately unread. A manufacturer name does not establish independent funding, noninvolvement or overall safety. Only existing bibliography is linked; external articles, abstracts, full texts, registration, protocols, analysis plans and support disclosures are unread. A URL, PMCID or registration number alone does not establish acquisition, accessibility, reading, prespecification or fulfilled conditions. The 2026-09-08 date recorded for every material is the original evidence date, not an actual external-reading date. The 2026-10-06 date describes original production. Production dates and pending-review labels are not completed clinical-review/external-verification dates; actual verification dates remain unrecorded.

Report counts versus independent study counts

The direct active-control report remains distinct from a follow-up narrative unlinked to a separate bibliography. Reports, trials, teams, participants and lesions are not substituted for or added to one another; unique-trial, participant and independent-replication counts remain unrecorded.

Review criteria

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

N01 · Which vitiligo/VASI question is addressed?

Required materials and conditions: Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation
Conditions for verification: Original records on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N02 · Who participated and what were the baseline vitiligo characteristics?

Required materials and conditions: The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution
Conditions for verification: Original records on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N03 · Does the oil terminology identify the actual formulation?

Required materials and conditions: Ground-seed extraction with 96% ethanol, followed by solvent evaporation
Conditions for verification: Original records on Ground-seed extraction with 96% ethanol, followed by solvent evaporation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Ground-seed extraction with 96% ethanol, followed by solvent evaporation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N04 · Are other Nigella formulations and routes distinguished?

Required materials and conditions: Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations
Conditions for verification: Original records on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N05 · Does the 100 g container specify the dose for 1 application?

Required materials and conditions: 2 daily applications, the 100 g container quantity and actual use
Conditions for verification: Original records on 2 daily applications, the 100 g container quantity and actual use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on 2 daily applications, the 100 g container quantity and actual use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N06 · How are 6 months and monthly measurements distinguished?

Required materials and conditions: 6 months of treatment/follow-up and monthly VASI measurement
Conditions for verification: Original records on 6 months of treatment/follow-up and monthly VASI measurement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on 6 months of treatment/follow-up and monthly VASI measurement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N07 · Is fish oil a placebo?

Required materials and conditions: Composition, administration and meaning of the topical fish-oil active comparison
Conditions for verification: Original records on Composition, administration and meaning of the topical fish-oil active comparison must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Composition, administration and meaning of the topical fish-oil active comparison is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N08 · Does this comparison answer phototherapy add-on or treatment-replacement questions?

Required materials and conditions: The selected active comparison versus phototherapy/standard-treatment combinations
Conditions for verification: Original records on The selected active comparison versus phototherapy/standard-treatment combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on The selected active comparison versus phototherapy/standard-treatment combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N09 · How is the direct report identified?

Required materials and conditions: Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI
Conditions for verification: Original records on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N10 · Does an IRCT number verify prospective registration?

Required materials and conditions: IRCT201201025069N5 and registration content, timing and history
Conditions for verification: Original records on IRCT201201025069N5 and registration content, timing and history must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on IRCT201201025069N5 and registration content, timing and history is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N11 · What are the VASI endpoint and prospective testing hierarchy?

Required materials and conditions: Prospective hierarchy of VASI change, monthly timepoints and body-site results
Conditions for verification: Original records on Prospective hierarchy of VASI change, monthly timepoints and body-site results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Prospective hierarchy of VASI change, monthly timepoints and body-site results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N12 · How were randomization and concealment performed?

Required materials and conditions: Allocation sequence, concealment and arm-specific recruitment flow
Conditions for verification: Original records on Allocation sequence, concealment and arm-specific recruitment flow must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Allocation sequence, concealment and arm-specific recruitment flow is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N13 · Were formulation-specific masking and assessor measurement maintained?

Required materials and conditions: Topical-preparation appearance/scent, participant/assessor masking and unmasking
Conditions for verification: Original records on Topical-preparation appearance/scent, participant/assessor masking and unmasking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Topical-preparation appearance/scent, participant/assessor masking and unmasking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N14 · Which denominators are described by 52 participants and no dropouts?

Required materials and conditions: Participants, arm-specific allocation, analysis, completion and lesion units
Conditions for verification: Original records on Participants, arm-specific allocation, analysis, completion and lesion units must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Participants, arm-specific allocation, analysis, completion and lesion units is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N15 · What are the missing-data rules and repeated-measures model assumptions?

Required materials and conditions: Monthly repeated measurement, missingness, ITT, clustering and adjusted models
Conditions for verification: Original records on Monthly repeated measurement, missingness, ITT, clustering and adjusted models must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Monthly repeated measurement, missingness, ITT, clustering and adjusted models is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N16 · How is VASI calculated and interpreted?

Required materials and conditions: VASI calculation, baseline body sites, assessors and repigmentation interpretation
Conditions for verification: Original records on VASI calculation, baseline body sites, assessors and repigmentation interpretation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on VASI calculation, baseline body sites, assessors and repigmentation interpretation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N17 · What are the before/after VASI values in each arm?

Required materials and conditions: Nigella/fish-oil means and variation values with arm correspondence
Conditions for verification: Original records on Nigella/fish-oil means and variation values with arm correspondence must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Nigella/fish-oil means and variation values with arm correspondence is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N18 · Which test does P<.020 at months 4–6 refer to?

Required materials and conditions: Monthly between-group results, prospective testing and exact timepoints
Conditions for verification: Original records on Monthly between-group results, prospective testing and exact timepoints must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Monthly between-group results, prospective testing and exact timepoints is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N19 · Is the exact 6-month between-group effect and interval available?

Required materials and conditions: The 6-month between-group estimate, 95% CI and effect type
Conditions for verification: Original records on The 6-month between-group estimate, 95% CI and effect type must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on The 6-month between-group estimate, 95% CI and effect type is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N20 · Was multiplicity across body sites and timepoints addressed?

Required materials and conditions: Body-site/monthly tests, multiplicity and selective reporting
Conditions for verification: Original records on Body-site/monthly tests, multiplicity and selective reporting must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Body-site/monthly tests, multiplicity and selective reporting is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N21 · Does repigmentation establish an effect at every body site?

Required materials and conditions: VASI, body-site effects, complete repigmentation and responders
Conditions for verification: Original records on VASI, body-site effects, complete repigmentation and responders must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on VASI, body-site effects, complete repigmentation and responders is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N22 · Is the 33-person/47-lesion follow-up narrative independent confirmation?

Required materials and conditions: 33 participants, 47 lesions, uncontrolled design and same-team follow-up
Conditions for verification: Original records on 33 participants, 47 lesions, uncontrolled design and same-team follow-up must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on 33 participants, 47 lesions, uncontrolled design and same-team follow-up is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N23 · What are the unique-trial/participant and independent-replication counts?

Required materials and conditions: Connections among the direct trial, narrative follow-up reference and multiple results
Conditions for verification: Original records on Connections among the direct trial, narrative follow-up reference and multiple results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Connections among the direct trial, narrative follow-up reference and multiple results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N24 · Does no specific funding mean independent funding?

Required materials and conditions: The no-specific-research-funding statement versus actual funding and roles
Conditions for verification: Original records on The no-specific-research-funding statement versus actual funding and roles must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on The no-specific-research-funding statement versus actual funding and roles is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N25 · Does a Giah Essence preparation establish product support or employee authorship?

Required materials and conditions: Manufacturer, product provision, author employment and conflicts
Conditions for verification: Original records on Manufacturer, product provision, author employment and conflicts must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Manufacturer, product provision, author employment and conflicts is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N26 · How were topical adverse events collected?

Required materials and conditions: Skin reactions, event definitions, arm-specific collection and exposure denominators
Conditions for verification: Original records on Skin reactions, event definitions, arm-specific collection and exposure denominators must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Skin reactions, event definitions, arm-specific collection and exposure denominators is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N27 · Are extraction methods, product composition and safety interchangeable?

Required materials and conditions: Product, extraction, constituent quantities and skin-exposure differences
Conditions for verification: Original records on Product, extraction, constituent quantities and skin-exposure differences must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Product, extraction, constituent quantities and skin-exposure differences is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N28 · Are vulnerable groups, concomitant medicines and longer-term harms answered?

Required materials and conditions: Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use
Conditions for verification: Original records on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N29 · Can this be extended to standard-treatment replacement, pure oil or creams?

Required materials and conditions: The selected ethanolic topical extract versus other products and treatment replacement
Conditions for verification: Original records on The selected ethanolic topical extract versus other products and treatment replacement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on The selected ethanolic topical extract versus other products and treatment replacement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N30 · What are the current Korean/English wording and English correction?

Required materials and conditions: Current Korean/English wording, the 1-field correction and generic English evidence wording
Conditions for verification: Original records on Current Korean/English wording, the 1-field correction and generic English evidence wording must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Current Korean/English wording, the 1-field correction and generic English evidence wording is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N31 · What are the original C/46, axes and historical cross-checking?

Required materials and conditions: C/46, EX/CX, all original axes and historical cross-checking
Conditions for verification: Original records on C/46, EX/CX, all original axes and historical cross-checking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on C/46, EX/CX, all original axes and historical cross-checking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

N32 · What are the dates, empty records and actual reading scope?

Required materials and conditions: Original evidence/correction dates, empty original values and stored-summary/external-unread scope
Conditions for verification: Original records on Original evidence/correction dates, empty original values and stored-summary/external-unread scope must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Why this condition is needed: Material on Original evidence/correction dates, empty original values and stored-summary/external-unread scope is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

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

Change history

2026-10-24 · Public page/material version 1.0

The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which vitiligo/VASI question is addressed?

Current findings: The original claim concerns reduced VASI and improved repigmentation in vitiligo. Its scope is an active-control comparison of topical ethanolic seed extract.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Placebo-controlled effects, standard-treatment replacement and direct effects of other products remain unverified.
Required materials and conditions: Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation
Materials to obtain first: Specifications of formulation, population, comparator and endpoint
Further research: Material needed: Specifications of formulation, population, comparator and endpoint. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Topical ethanolic Nigella seed extract versus fish oil for VASI/repigmentation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N02 · Who participated and what were the baseline vitiligo characteristics?

Current findings: The retained use conditions describe 52 participants/adults with vitiligo.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed diagnosis, disease type/activity, history, baseline lesion distribution and exclusions remain unverified.
Required materials and conditions: The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution
Materials to obtain first: Eligibility, baseline-characteristic and lesion-distribution material
Further research: Material needed: Eligibility, baseline-characteristic and lesion-distribution material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The 52 participants/adults with vitiligo, diagnosis, type and lesion distribution is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N03 · Does the oil terminology identify the actual formulation?

Current findings: The retained manuscript describes the article's oil preparation as a 96% ethanolic seed extract, rather than simply pressed oil.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed final composition, residual solvent, extraction yield, quantification and batches remain unverified.
Required materials and conditions: Ground-seed extraction with 96% ethanol, followed by solvent evaporation
Materials to obtain first: Extraction, final-composition, batch and quantification material
Further research: Material needed: Extraction, final-composition, batch and quantification material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Ground-seed extraction with 96% ethanol, followed by solvent evaporation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Ground-seed extraction with 96% ethanol, followed by solvent evaporation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N04 · Are other Nigella formulations and routes distinguished?

Current findings: The selected route is topical skin application. The original restricts interchangeability among other Nigella formulations, purified constituents and combinations.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Equivalent effects of other formulations/routes remain unverified.
Required materials and conditions: Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations
Materials to obtain first: Direct comparison material separated by formulation and route
Further research: Material needed: Direct comparison material separated by formulation and route. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Topical skin use versus seed powder, fixed oil, aqueous extract, purified thymoquinone and combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N05 · Does the 100 g container specify the dose for 1 application?

Current findings: The retained dose description is 2 applications to lesions daily; 100 g is the container quantity, and the dose for 1 application is unverified.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The dose for 1 application, per-area application, actual use, cumulative exposure and adherence remain unverified. Container quantity is not converted into a daily dose.
Required materials and conditions: 2 daily applications, the 100 g container quantity and actual use
Materials to obtain first: Application, area, use-quantity and adherence records
Further research: Material needed: Application, area, use-quantity and adherence records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on 2 daily applications, the 100 g container quantity and actual use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on 2 daily applications, the 100 g container quantity and actual use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N06 · How are 6 months and monthly measurements distinguished?

Current findings: The retained duration is 6 months, with VASI described as monthly repeated measurement.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed measurement schedules, post-treatment persistence, relapse and longer follow-up remain unverified.
Required materials and conditions: 6 months of treatment/follow-up and monthly VASI measurement
Materials to obtain first: Monthly measurement and follow-up schedules
Further research: Material needed: Monthly measurement and follow-up schedules. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on 6 months of treatment/follow-up and monthly VASI measurement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on 6 months of treatment/follow-up and monthly VASI measurement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N07 · Is fish oil a placebo?

Current findings: The retained comparator is topical fish oil, an active comparator. Within-group changes in both arms are not converted into a placebo-controlled effect.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed comparator composition, dose, matched application/shared care and the meaning of active control remain unverified.
Required materials and conditions: Composition, administration and meaning of the topical fish-oil active comparison
Materials to obtain first: Fish-oil, administration and shared-care specifications
Further research: Material needed: Fish-oil, administration and shared-care specifications. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Composition, administration and meaning of the topical fish-oil active comparison must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Composition, administration and meaning of the topical fish-oil active comparison is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N08 · Does this comparison answer phototherapy add-on or treatment-replacement questions?

Current findings: The original distinguishes this preparation from pure oil, creams and standard-phototherapy combinations.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Use/changes of concomitant standard treatment and direct treatment-replacement comparisons remain unverified.
Required materials and conditions: The selected active comparison versus phototherapy/standard-treatment combinations
Materials to obtain first: Concomitant-treatment, phototherapy and rescue-treatment material
Further research: Material needed: Concomitant-treatment, phototherapy and rescue-treatment material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on The selected active comparison versus phototherapy/standard-treatment combinations must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The selected active comparison versus phototherapy/standard-treatment combinations is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N09 · How is the direct report identified?

Current findings: The retained bibliography records the 2014 report, PMID 25068060, PMCID PMC4102993 and DOI 10.5812/ircmj.4515.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Current external bibliographic material, article files and full text remain unread in this work.
Required materials and conditions: Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI
Materials to obtain first: The direct original article and bibliographic record
Further research: Material needed: The direct original article and bibliographic record. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Retained links for the Ghorbanibirgani report, PMID, PMCID and DOI is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N10 · Does an IRCT number verify prospective registration?

Current findings: The retained evidence-table registration field and bibliography record IRCT201201025069N5. The identifier is not promoted to actual registration reading.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Registration content, prospective timing, amendments and endpoint correspondence remain unread.
Required materials and conditions: IRCT201201025069N5 and registration content, timing and history
Materials to obtain first: Registration content, protocol and amendment history
Further research: Material needed: Registration content, protocol and amendment history. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on IRCT201201025069N5 and registration content, timing and history must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on IRCT201201025069N5 and registration content, timing and history is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N11 · What are the VASI endpoint and prospective testing hierarchy?

Current findings: The original marks the exact 6-month between-group effect, 95% CI and prospective testing hierarchy as unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: A single prospective primary endpoint, timepoint, body-site/test hierarchy and multiplicity plan remain unverified.
Required materials and conditions: Prospective hierarchy of VASI change, monthly timepoints and body-site results
Materials to obtain first: Registration, protocol and SAP
Further research: Material needed: Registration, protocol and SAP. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Prospective hierarchy of VASI change, monthly timepoints and body-site results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Prospective hierarchy of VASI change, monthly timepoints and body-site results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N12 · How were randomization and concealment performed?

Current findings: The retained design description is a randomized, double-blind, active-controlled trial.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed sequence generation, concealment, arm-specific recruitment and eligibility application remain unverified.
Required materials and conditions: Allocation sequence, concealment and arm-specific recruitment flow
Materials to obtain first: Allocation, concealment and participant-flow material
Further research: Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Allocation sequence, concealment and arm-specific recruitment flow must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Allocation sequence, concealment and arm-specific recruitment flow is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N13 · Were formulation-specific masking and assessor measurement maintained?

Current findings: The report is retained as describing double blinding.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed sensory matching, who was masked, unmasking and VASI-assessor procedures remain unverified.
Required materials and conditions: Topical-preparation appearance/scent, participant/assessor masking and unmasking
Materials to obtain first: Preparation, masking and assessment methods
Further research: Material needed: Preparation, masking and assessment methods. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Topical-preparation appearance/scent, participant/assessor masking and unmasking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Topical-preparation appearance/scent, participant/assessor masking and unmasking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N14 · Which denominators are described by 52 participants and no dropouts?

Current findings: The retained sample description is 52 participants with no dropouts. Participant and lesion counts are not interchanged.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed arm-specific allocation, VASI analysis counts, analysis-population definitions and lesion-clustering treatment remain unverified.
Required materials and conditions: Participants, arm-specific allocation, analysis, completion and lesion units
Materials to obtain first: Arm-specific flow, endpoint denominators and lesion-analysis material
Further research: Material needed: Arm-specific flow, endpoint denominators and lesion-analysis material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Participants, arm-specific allocation, analysis, completion and lesion units must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Participants, arm-specific allocation, analysis, completion and lesion units is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N15 · What are the missing-data rules and repeated-measures model assumptions?

Current findings: The original describes repeated-measures analysis as reporting differences at months 4–6.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Missing-data handling, ITT, correlation structure, lesion clustering, adjustment variables and model assumptions remain unverified.
Required materials and conditions: Monthly repeated measurement, missingness, ITT, clustering and adjusted models
Materials to obtain first: SAP, repeated-measures and missing-data analysis material
Further research: Material needed: SAP, repeated-measures and missing-data analysis material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Monthly repeated measurement, missingness, ITT, clustering and adjusted models must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Monthly repeated measurement, missingness, ITT, clustering and adjusted models is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N16 · How is VASI calculated and interpreted?

Current findings: The selected endpoint is VASI change, recorded as monthly repeated measurement.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed scale calculation, body-site contributions, assessor reliability and repigmentation interpretation remain unverified.
Required materials and conditions: VASI calculation, baseline body sites, assessors and repigmentation interpretation
Materials to obtain first: VASI methods, baseline lesions and assessment material
Further research: Material needed: VASI methods, baseline lesions and assessment material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on VASI calculation, baseline body sites, assessors and repigmentation interpretation must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on VASI calculation, baseline body sites, assessors and repigmentation interpretation is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N17 · What are the before/after VASI values in each arm?

Current findings: The retained result is 4.98±4.81→3.75±3.91 versus 4.98±4.80→4.62±4.36. Order and values are retained.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The statistical meaning of ±, original tables, arm-specific denominators and exact between-group change remain unverified. Within-group and between-group differences are not newly calculated.
Required materials and conditions: Nigella/fish-oil means and variation values with arm correspondence
Materials to obtain first: Original arm-specific VASI tables, denominators and analysis definitions
Further research: Material needed: Original arm-specific VASI tables, denominators and analysis definitions. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Nigella/fish-oil means and variation values with arm correspondence must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Nigella/fish-oil means and variation values with arm correspondence is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N18 · Which test does P<.020 at months 4–6 refer to?

Current findings: The retained result is between-group P<.020 at months 4–6. The original describes reported differences from month 4 onward.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Exact monthly tests, P values, adjustment and prospective hierarchy remain unverified.
Required materials and conditions: Monthly between-group results, prospective testing and exact timepoints
Materials to obtain first: Monthly repeated measurement, between-group tests and SAP
Further research: Material needed: Monthly repeated measurement, between-group tests and SAP. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Monthly between-group results, prospective testing and exact timepoints must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Monthly between-group results, prospective testing and exact timepoints is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N19 · Is the exact 6-month between-group effect and interval available?

Current findings: The original marks the exact 6-month between-group effect and 95% CI as unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Between-group estimates, intervals and adjusted models are absent from the retained material. No new CI is calculated from retained means, variation values or the 52 participants.
Required materials and conditions: The 6-month between-group estimate, 95% CI and effect type
Materials to obtain first: The 6-month between-group estimate, 95% CI and model output
Further research: Material needed: The 6-month between-group estimate, 95% CI and model output. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on The 6-month between-group estimate, 95% CI and effect type must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The 6-month between-group estimate, 95% CI and effect type is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N20 · Was multiplicity across body sites and timepoints addressed?

Current findings: The original records multiplicity concerns across body-site tests and timepoints.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The full set of tests, adjustment, prospective hierarchy and unreported results remain unverified.
Required materials and conditions: Body-site/monthly tests, multiplicity and selective reporting
Materials to obtain first: Results for all body sites/timepoints and SAP
Further research: Material needed: Results for all body sites/timepoints and SAP. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Body-site/monthly tests, multiplicity and selective reporting must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Body-site/monthly tests, multiplicity and selective reporting is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N21 · Does repigmentation establish an effect at every body site?

Current findings: The original states that complete repigmentation and efficacy at every body site were not established.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Exact site-specific effects, responder criteria, complete-repigmentation denominators and CIs remain unverified.
Required materials and conditions: VASI, body-site effects, complete repigmentation and responders
Materials to obtain first: Body-site, responder and repigmentation results
Further research: Material needed: Body-site, responder and repigmentation results. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on VASI, body-site effects, complete repigmentation and responders must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on VASI, body-site effects, complete repigmentation and responders is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N22 · Is the 33-person/47-lesion follow-up narrative independent confirmation?

Current findings: The original supplementary summary describes the 33-person/47-lesion follow-up as uncontrolled and from the same team, and did not count it as independent confirmation. The current bibliography identifies the direct trial, rather than linking the follow-up report.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The follow-up report title/bibliography, exact formulation, original-cohort overlap and lesion analysis remain unverified in this input.
Required materials and conditions: 33 participants, 47 lesions, uncontrolled design and same-team follow-up
Materials to obtain first: Follow-up bibliography, participant/lesion and cohort-linkage material
Further research: Material needed: Follow-up bibliography, participant/lesion and cohort-linkage material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on 33 participants, 47 lesions, uncontrolled design and same-team follow-up must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on 33 participants, 47 lesions, uncontrolled design and same-team follow-up is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N23 · What are the unique-trial/participant and independent-replication counts?

Current findings: The direct active-control report remains distinct from the narrative follow-up reference. The 52 participants, 33 participants and 47 lesions are not newly summed into participant totals or independent replication.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Exact report–trial–cohort relationships, unique participants and independent-replication counts remain unverified.
Required materials and conditions: Connections among the direct trial, narrative follow-up reference and multiple results
Materials to obtain first: A report–trial–cohort–lesion linkage table
Further research: Material needed: A report–trial–cohort–lesion linkage table. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Connections among the direct trial, narrative follow-up reference and multiple results must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Connections among the direct trial, narrative follow-up reference and multiple results is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N24 · Does no specific funding mean independent funding?

Current findings: The retained funding description reports no specific research funding; the original restricts claims of independently funded strengths as unverified.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Funding sources, cost coverage and design/analysis/publication roles remain unverified.
Required materials and conditions: The no-specific-research-funding statement versus actual funding and roles
Materials to obtain first: Research-funding, role and cost disclosures
Further research: Material needed: Research-funding, role and cost disclosures. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on The no-specific-research-funding statement versus actual funding and roles must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The no-specific-research-funding statement versus actual funding and roles is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N25 · Does a Giah Essence preparation establish product support or employee authorship?

Current findings: The retained funding record names a Giah Essence Phytopharm preparation. A manufacturer name does not replace separate verification of support, employee authorship or conflicts.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Individual material on free product provision, manufacturer involvement, employee authorship and declared conflicts remains unverified.
Required materials and conditions: Manufacturer, product provision, author employment and conflicts
Materials to obtain first: Original product-support, author-affiliation and conflict disclosures
Further research: Material needed: Original product-support, author-affiliation and conflict disclosures. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Manufacturer, product provision, author employment and conflicts must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Manufacturer, product provision, author employment and conflicts is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N26 · How were topical adverse events collected?

Current findings: The original states that small trials cannot exclude rare adverse events or establish long-term safety.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Detailed skin adverse events, collection methods, arm-specific events, exposure/lesion denominators and discontinuation remain unverified.
Required materials and conditions: Skin reactions, event definitions, arm-specific collection and exposure denominators
Materials to obtain first: Skin-event, collection and exposure-denominator material
Further research: Material needed: Skin-event, collection and exposure-denominator material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Skin reactions, event definitions, arm-specific collection and exposure denominators must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Skin reactions, event definitions, arm-specific collection and exposure denominators is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N27 · Are extraction methods, product composition and safety interchangeable?

Current findings: The original states that constituent quantities can vary by product and extraction method.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Product-specific constituents, skin exposure, longer-term events and safety correspondence with other formulations remain unverified.
Required materials and conditions: Product, extraction, constituent quantities and skin-exposure differences
Materials to obtain first: Formulation, constituent-quantity, exposure and safety material
Further research: Material needed: Formulation, constituent-quantity, exposure and safety material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Product, extraction, constituent quantities and skin-exposure differences must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Product, extraction, constituent quantities and skin-exposure differences is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

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N28 · Are vulnerable groups, concomitant medicines and longer-term harms answered?

Current findings: The retained safety wording records precautions for the relevant vulnerable-group/concomitant-medicine situations and limitations of long-term safety evidence.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct event comparisons, longer follow-up and exposure denominators by population and concomitant medicine remain unverified.
Required materials and conditions: Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use
Materials to obtain first: Vulnerable-group, concomitant-medicine and longer-term harm material
Further research: Material needed: Vulnerable-group, concomitant-medicine and longer-term harm material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Pregnancy, breastfeeding, children, liver/kidney conditions, concomitant medicines and perioperative use is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N29 · Can this be extended to standard-treatment replacement, pure oil or creams?

Current findings: The original restricts standard-treatment replacement, pure oil, creams and phototherapy combinations as different questions.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct comparison effects for standard-treatment replacement and other products remain unverified.
Required materials and conditions: The selected ethanolic topical extract versus other products and treatment replacement
Materials to obtain first: Direct comparisons of replacement, combinations and other formulations
Further research: Material needed: Direct comparisons of replacement, combinations and other formulations. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on The selected ethanolic topical extract versus other products and treatment replacement must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The selected ethanolic topical extract versus other products and treatment replacement is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N30 · What are the current Korean/English wording and English correction?

Current findings: The current Korean/English wording and the 1-field English correction on 2026-09-14 are retained. Generic English verification wording is not inherited as current quantitative or original-source verification.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Before/after English correction texts and detailed original-source correspondence for individual fields remain unread.
Required materials and conditions: Current Korean/English wording, the 1-field correction and generic English evidence wording
Materials to obtain first: Before/after correction and language-correspondence material
Further research: Material needed: Before/after correction and language-correspondence material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Current Korean/English wording, the 1-field correction and generic English evidence wording must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Current Korean/English wording, the 1-field correction and generic English evidence wording is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N31 · What are the original C/46, axes and historical cross-checking?

Current findings: C/46, all original axes and historical cross-check wording are preserved as historical values. Uncertainty is not regraded as no effect or inherited as newly completed content review.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Review of the retained clinical content remains incomplete.
Required materials and conditions: C/46, EX/CX, all original axes and historical cross-checking
Materials to obtain first: Feedback and future correction material
Further research: Material needed: Feedback and future correction material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on C/46, EX/CX, all original axes and historical cross-checking must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on C/46, EX/CX, all original axes and historical cross-checking is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01

N32 · What are the dates, empty records and actual reading scope?

Current findings: The retained original material was used for preparation. The original evidence date 2026-09-08, correction date 2026-09-14, empty subsidiary-claim records and empty additional discussion are retained.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols, analysis plans and support disclosures remain unread, with no access attempt.
Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt. External source links were not access-tested.
Required materials and conditions: Original evidence/correction dates, empty original values and stored-summary/external-unread scope
Materials to obtain first: Needed original material and extraction/denominator/timepoint material when supplied
Further research: Material needed: Needed original material and extraction/denominator/timepoint material when supplied. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in the actual formulation, application amount, randomized/analysis denominators, VASI and dispersion, exact between-group effects and intervals, prospective timepoints, repeated measurements/multiplicity, follow-up report correspondence, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.
Conditions for verification: Original records on Original evidence/correction dates, empty original values and stored-summary/external-unread scope must link to the relevant report, trial, participant/lesion and analysis units, timing and denominator, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Original evidence/correction dates, empty original values and stored-summary/external-unread scope is needed to connect the relevant extracted formulation, topical route, population, active comparator, VASI, timing, participant/lesion units, denominator or harm scope.
Application exceptions: Active-control and placebo comparisons, within-group changes and between-group effects, monthly/site-specific testing and a prospective principal timepoint, and participants versus lesions remain distinct. Findings are not extended to other formulations or routes, complete repigmentation, every body site, standard-treatment replacement or overall safety.
Referenced methods: Existing principles distinguish formulation, topical route, population, active comparator, VASI, timing, participants versus lesions, denominators, repeated measurements, support and harms in the retained vitiligo record.

Related sources S01