An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0… (NCT07105254) | Clinical Trial Compass
RecruitingPhase 2
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)
United States20 participantsStarted 2025-08-01
Plain-language summary
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)
Who can participate
Age range2 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Subjects with known or suspected:
✕. 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.
What they're measuring
1
The primary endpoint of this study is the number patients achieving F-VASI 50.
✕. Subjects who are unwilling to refrain from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
✕. Subjects with diagnosis of other forms of vitiligo (e.g. Segmental), other differential diagnosis of vitiligo or other skin depigmentation disorders (e.g. Piedbaldism, pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma and tinea versicolor) that would interfere with the evaluations of the effect of the study medication, as determined by the Investigator.
✕. Subjects with known genetic dermatological conditions that overlap with non-segmental vitiligo.