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
4 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
Researchers are evaluating the effectiveness of Roflumilast foam 0.3% in children and adolescents with Non-Segmental Vitiligo (NSV), a condition causing skin depigmentation. This open-label, single-center, proof of concept study focuses on pediatric patients aged 2 to 18 years. The primary goal is to assess how many patients achieve at least 50% improvement in facial Vitiligo Area Scoring Index (F-VASI) at 24 weeks. Participants will apply Roflumilast 0.3% topical foam during the study. This treatment is being studied in a single group without a placebo comparison. The study lasts for 24 weeks, during which patients will regularly use the foam and undergo evaluations to track changes in their vitiligo. Throughout the study, participants will have visits at baseline and at weeks 4, 8, 12, 18, and 24. Researchers will measure skin changes using various Vitiligo Area Scoring Index scores and patient assessments such as the Patient Global Impression of Change-Vitiligo and Vitiligo Noticeability Scale. The study also monitors safety and adherence to treatment. The total participation time is approximately 24 weeks.
CONDITIONS
Brief 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 from parent(s) or legal guardian and assent from subjects if age appropriate
- Diagnosis of non-segmental vitiligo for at least 3 months based on clinical history and dermatology exam
- Body surface area affected less than 10% with at least 0.5% affected on the face
- Presence of pigmented hair within some facial areas of vitiligo
- Good health as determined by the Investigator
- Subjects and guardians capable of adhering to study protocol and visit schedule
You will not qualify if you...
- Serious medical conditions or physical abnormalities preventing safe participation
- Severe renal insufficiency or moderate to severe liver disorders
- Inability to stop prohibited medications or treatments before and during the study
- Unwillingness to avoid tanning beds or artificial light sources during study period
- Other forms of vitiligo or skin depigmentation disorders that interfere with evaluations
- Known genetic dermatological conditions overlapping with non-segmental vitiligo
- Allergies to ingredients in Roflumilast foam
- Use of systemic CYP3A4 or dual CYP3A4 and CYP1A2 inhibitors
- Use of oral roflumilast within 4 weeks before study start
- Pregnancy, breastfeeding, or wishing to become pregnant during the study
- Prior treatment with Roflumilast cream or foam for vitiligo within 3 months
- Inability to communicate or understand the local language
- Family members of study site staff, sponsors, or enrolled subjects living in the same household
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive Roflumilast 0.3% topical foam as the study treatment.
Visits at baseline, and weeks 4, 8, 12, 18, and 24
Trial Site Locations
Total: 1 location
1
Derm Texas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Amanda Harvey, Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here