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)
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- Derm Texas, PLLC
- Study ID
- NCT07105254
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast topical 0.3% foam — DRUGRoflumilast 0.3% topical foam
Study Details
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)
Key Dates
- Start date
- Aug 1, 2025
- Status verified
- Aug 2025
- Primary completion
- May 15, 2026
- Completion
- Jun 15, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3%
Primary Outcome Measure
The primary endpoint of this study is the number patients achieving F-VASI 50. [ Time Frame: Week 24 ]
Central Contacts
- Amanda Harvey, Study Coordinator2148456426
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Derm Texas | Dallas | Texas | 75235 | Kelly Warren, MD (PRINCIPAL_INVESTIGATOR) |
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