Roflumilast 0.3% foam for children with non-segmental vitiligo

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)

This trial will try a roflumilast 0.3% topical foam to see if it helps children and teens (ages 2–17) with non-segmental vitiligo affecting small areas including the face.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 2 Years to 18 Years
• Sex: All
• Sponsor: Derm Texas, PLLC (Research network)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07105254 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-center, Phase 2 proof-of-concept trial testing topical roflumilast 0.3% foam in pediatric patients with non-segmental vitiligo. Eligible participants are ages 2 to less than 18 years with disease for at least 3 months, total body surface area (BSA) affected under 10%, at least 0.5% BSA on the face, and pigmented hair in some facial lesions. The foam is applied to affected areas and subjects are followed with dermatologic examinations to document changes in pigmentation and clinical status. The trial is conducted at a single site (Derm Texas in Dallas, Texas) in collaboration with Arcutis Biotherapeutics.

Who should consider this trial

Good fit: Children and adolescents aged 2 to under 18 with non-segmental vitiligo for at least 3 months, total BSA <10%, at least 0.5% BSA affected on the face, and pigmented hair in some facial lesions who are otherwise in good health and can follow the visit schedule.

Not a fit: Patients with extensive vitiligo (>10% BSA), segmental vitiligo, no pigmented hair in affected facial areas, or serious medical conditions that prevent participation are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, topical roflumilast could offer a non-systemic treatment that helps repigment small areas of vitiligo in children.

How similar studies have performed: Topical PDE4 inhibition for vitiligo is a relatively novel approach with limited prior pediatric data and only early or limited reports in adults, so direct evidence of success is currently sparse.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects aged 2 years but less than 18 years
2. 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.
3. Diagnosis of non-segmental vitiligo based on clinical history and dermatology examination for at least 3 months.
4. Diagnosis of non-segmental vitiligo with the following:

   1. BSA affected \< 10% AND
   2. At least 0.5% BSA affected on the face. AND
   3. Pigmented hair within some of the areas of vitiligo on the face
5. In good health as judged by the Investigator, based on the medical history, and dermatology examination.
6. 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.

Exclusion Criteria:

1. 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.
2. Subjects with known or suspected:

   1. Severe renal insufficiency
   2. Moderate to severe hepatic disorders (Child-Pugh B or C)
   3. 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.
3. 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.
4. 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.
5. Subjects with known genetic dermatological conditions that overlap with non-segmental vitiligo.
6. Known allergies to excipients in Roflumilast foam (petrolatum, isopopyl palmitate, methylparaben, propylparaben, diethylene glycol monomethyl ether, hexylene glycol, cetylseteary alcohol, dicetyl phosphase and ceteth-10 phosphate)
7. Subjects who cannot discontinue systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g. Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine)
8. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/Day 1.
9. Females who are pregnant, wishing to become pregnant during the study, or are breast feeding.
10. Previous treatment with Roflumilast cream or foam for vitiligo in the past 3 months.
11. Parent (s)/legal guardians (s) who are unable to communicate, read, or understand the local language (s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
12. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Where this trial is running

Dallas, Texas

• Derm Texas — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Kelly Warren, MD — Derm Texas, PLLC
• Study coordinator: Amanda Harvey, Study Coordinator

Conditions Non-segmental Vitiligo