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.
Derm Texas, PLLC
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator