A Phase 2 interventional study of Roflumilast topical 0.3% foam in Non-segmental Vitiligo, sponsored by Derm Texas, PLLC. Recruiting at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Derm Texas, PLLC · Phase 2, Interventional, and Treatment
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)
This is the only study on the registry with Derm Texas, PLLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Diagnosis of non-segmental vitiligo with the following:
Exclusion Criteria:
Subjects with known or suspected:
Drug: Roflumilast topical 0.3% foam
Roflumilast 0.3% topical foam
The primary endpoint of this study is the number patients achieving F-VASI 50.
The number of patients achieving a 50% improvement in their facial Vitiligo Area \& Severity Index score (F-VASI 50) at week 24.
Time frame: Week 24
- Percentage of patients achieving: T-VASI50, T-VASI75, T-VASI90, and T-VASI100; F-VASI75, F-VASI90, and F-VASI100 at 24 weeks. Patient Assessments of - Patient Global Impression of Change-Vitiligo (PaGIC-V) - Vitiligo Noticeability Scale (VNS)
The percentage of patients who achieve improvements of 50%, 75%, 90% and100% from baseline to week 24 in their facial and total VASI scores. (F-VASI-50, 75, 90, 100 \& T-VASI-50, 75, 90, 100). Patients will assess their impression of vitiligo change and noticeability over the course of the study.
Time frame: Baseline, the at weeks 4, 8, 12, 18 & 24.
Plan to share: Undecided
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