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Phase 3 Trial of Ruxolitinib Cream for Treating Nonsegmental Vitiligo in Children Ages 6 to Under 12
Researchers are studying the use of ruxolitinib cream in children aged 6 to under 12 years who have nonsegmental vitiligo. The study aims to evaluate how well and how safely the cream works for treating this condition, which causes loss of skin color. This is a Phase 3 clinical trial focused on treatment effects in this pediatric population. Participants are assigned to one of three groups receiving either ruxolitinib cream at 0.75% or 1.5%, or a matching vehicle placebo cream. Each cream is applied topically as a thin film twice daily to the affected skin areas as defined in the study protocol. The treatment period lasts up to 24 weeks, during which changes in skin pigmentation are monitored. Throughout the study, participants undergo regular assessments including evaluations of vitiligo improvement on the face and body using the Vitiligo Area Scoring Index and other scales. Safety is monitored by tracking adverse events and blood levels of the drug at multiple timepoints up to 52 weeks. Quality of life and psychosocial effects are also measured. The total study duration includes treatment and follow-up visits to assess long-term outcomes and safety.