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Ruxolitinib cream for children ages 6 to 11
Official title: A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Status: Recruiting now
Description:
This Phase 3 study is evaluating the safety and efficacy of ruxolitinib cream in children ages 6–11 with nonsegmental vitiligo.
During the first 24 weeks, participants receive one of two strengths of ruxolitinib cream or a matching cream (called "vehicle") with no active medicine. Study cream is applied twice daily.
Participation continues for up to 52 weeks, followed by a safety follow-up.
Basic eligibility includes measurable nonsegmental vitiligo on the face and body: at least 0.5% of body surface area on the face and at least 3% on nonfacial areas, with no more than 10% total body involvement. Other criteria apply, including requirements concerning current and recent vitiligo treatments.
Sites are located in Argentina and 13 European countries. There are no U.S. or Canadian sites. The research site determines eligibility. Use of ruxolitinib cream for vitiligo in this age group is investigational.
Related pediatric study: View the study for children ages 2–11 in the United States and Canada
Start date: November 13, 2025
Completion date: December 01, 2027
Organizer: Incyte Corporation
Contact: Incyte Corporation Call Center (US)
Tel.: +1-855-463-3463
Email: medinfo@incyte.com
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