A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Incyte Corporation
Summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Eligibility
- Age range
- 2–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI. * Total body vitiligo area does not exceed 10% BSA. * Pigmented hair within some of the areas of vitiligo on the face. * Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. * For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last applicat…
Interventions
- DrugRuxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
- DrugVehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Locations (99)
- University of Alabama At Birmingham-School of MedicineBirmingham, Alabama
- Phoenix Children'S HospitalPhoenix, Arizona
- Omni DermatologyPhoenix, Arizona
- Affiliated DermatologyScottsdale, Arizona
- Banner - University Medicine Multispecialty Services ClinicTucson, Arizona
- Premier Dermatology Clinical Trials Institute At Northwest ArkansasFayetteville, Arkansas