An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)
Derm Texas, PLLC
Summary
An open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% in pediatric subjects with Non-Segmental Vitiligo (NSV)
Eligibility
- Age range
- 2–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects aged 2 years but less than 18 years 2. Pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws. 3. Diagnosis of non-segmental vitiligo based on clinical history and dermatology examination for at least 3 months. 4. Diagnosis of non-segmental vitiligo with the following: 1. BSA affected \< 10% AND 2. At least 0.5% BSA affected on the face. AND 3. Pigmented hair within some of the areas of vitiligo on the face 5. In good health as judged…
Interventions
- DrugRoflumilast topical 0.3% foam
Roflumilast 0.3% topical foam
Location
- Derm TexasDallas, Texas