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)
Male or female subjects aged 2 years but less than 18 years
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.
Diagnosis of non-segmental vitiligo based on clinical history and dermatology examination for at least 3 months.
BSA affected < 10% AND
Subjects with any serious medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
Severe renal insufficiency
Moderate to severe hepatic disorders (Child-Pugh B or C)
Subjects who cannot discontinue prohibited medications and treatments prior to the Baseline visit and during the study, including (any biologic or experimental therapy within 12 weeks (or 5 half-lives), phototherapy within 4 weeks, immunomodulating treatments within 4 weeks, or topical treatments within 1 week.
Single group
Roflumilast topical 0.3% foam
DrugRoflumilast 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.
- 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.
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Derm Texas, PLLC
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator
