Ruxolitinib cream for childhood vitiligo

Resolution Criteria Trial: NCT06804811 Selected endpoint key: 0bc6a7e5ae47bd559f30e654d029e4690e3e14fffa06555dea4326c28bdbc912 Selected endpoint: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) Endpoint type: other Protocol outcome group: primary Endpoint description: ≥75% improvement in facial Vitiligo Area Scoring Index. Endpoint timeframe: Week 24 ClinicalTrials.gov population: Children aged 6 to <12 years with nonsegmental vitiligo Market population: Children aged 6 to <12 years with nonsegmental vitiligo Analysis set: Not specified in the enumerated protocol outcome Comparison: Ruxolitinib cream versus vehicle cream Success direction: higher Success rule: At Week 24, the proportion of participants achieving at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) must be higher with ruxolitinib cream than with vehicle cream and must meet the prespecified statistical success criterion. The source does not specify an analysis set or a numerical between-group threshold. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06804811?tab=researcher#outcome-measures:~:text=Proportion%20of%20Participants%20Achieving%20a%20%E2%89%A5%2075%25%20Improvement%20From%20Baseline%20in%20the%20Facial%20Vitiligo%20Area%20Scoring%20Index%20(F-VASI75) YES 1. The exact selected endpoint (Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: Admin-selected market resolution deadline: 2027-12-31. The ClinicalTrials.gov record retrieved on 2026-10-06 lists estimated primary completion on 2027-04-30 for this exact study. The later December 31 cutoff allows time for analysis and disclosure. This is an administrative contract cutoff, not a sponsor-promised readout date; disclosure timing remains uncertain and the approved no-disclosure-by-deadline rule applies. Deadline evidence source: https://clinicaltrials.gov/study/NCT06804811 Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.