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)
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.
• Diagnosis of non-segmental vitiligo with the following:
‣ BSA affected \< 10% AND
⁃ At least 0.5% BSA affected on the face. AND
⁃ Pigmented hair within some of the areas of vitiligo on the face
• In good health as judged by the Investigator, based on the medical history, and dermatology examination.
• Subjects and parent(s)/legal guardian (s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.