Actively Recruiting
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)
Led by Derm Texas, PLLC · Updated on 2025-08-08
20
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
D
Derm Texas, PLLC
Lead Sponsor
A
Arcutis Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 2 years but less than 18 years
- Informed consent of parent(s) or legal guardian, and assent by subjects if age appropriate
- Diagnosis of non-segmental vitiligo for at least 3 months
- Body surface area affected less than 10% and at least 0.5% of face affected
- Presence of pigmented hair in some affected facial areas
- Good health based on medical history and dermatology exam
- Subjects and guardians capable of following study protocol and visit schedule
You will not qualify if you...
- Serious medical condition or physical abnormality that risks participation
- Severe renal insufficiency
- Moderate to severe liver disorders (Child-Pugh B or C)
- Unable to stop prohibited medications or treatments before and during study
- Unwilling to avoid tanning beds or artificial light devices during study
- Diagnosis of segmental vitiligo or other skin depigmentation disorders interfering with assessments
- Known genetic skin conditions overlapping with non-segmental vitiligo
- Allergy to ingredients in Roflumilast foam
- Unable to discontinue systemic CYP3A4 or dual CYP3A4/CYP1A2 inhibitors
- Received oral roflumilast within 4 weeks before baseline
- Pregnant, breastfeeding, or planning pregnancy during study
- Previous treatment with Roflumilast cream or foam for vitiligo within 3 months
- Inability of parents/legal guardians or subjects to read or understand local language
- Family members of study site staff, sponsor, or other enrolled subjects living in the same house
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Derm Texas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Amanda Harvey, Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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