Roflumilast 0.3% foam for children with non-segmental vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Derm Texas
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Kelly Warren, MD — Derm Texas, PLLC
• Study coordinator: Amanda Harvey, Study Coordinator
• Email: aharvey@derm-texas.com
• Phone: 2148456426

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.