CClinicalTrials.gg
RecruitingNCT07105254Updated Aug 8, 2025

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)

A Phase 2 interventional study of Roflumilast topical 0.3% foam in Non-segmental Vitiligo, sponsored by Derm Texas, PLLC. Recruiting at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Derm Texas, PLLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
2 Years to 18 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Non-segmental Vitiligo
03

In context

Lead sponsor

This is the only study on the registry with Derm Texas, PLLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3%

    Drug: Roflumilast topical 0.3% foam

Interventions

  • DrugRoflumilast topical 0.3% foam

    Roflumilast 0.3% topical foam

06

What researchers measure

Primary outcomes

  1. The primary endpoint of this study is the number patients achieving F-VASI 50.

    The number of patients achieving a 50% improvement in their facial Vitiligo Area \& Severity Index score (F-VASI 50) at week 24.

    Time frame: Week 24

Secondary outcomes

  1. - Percentage of patients achieving: T-VASI50, T-VASI75, T-VASI90, and T-VASI100; F-VASI75, F-VASI90, and F-VASI100 at 24 weeks. Patient Assessments of - Patient Global Impression of Change-Vitiligo (PaGIC-V) - Vitiligo Noticeability Scale (VNS)

    The percentage of patients who achieve improvements of 50%, 75%, 90% and100% from baseline to week 24 in their facial and total VASI scores. (F-VASI-50, 75, 90, 100 \& T-VASI-50, 75, 90, 100). Patients will assess their impression of vitiligo change and noticeability over the course of the study.

    Time frame: Baseline, the at weeks 4, 8, 12, 18 & 24.

07

Study locations

1 of 1 sites recruiting
  • Derm Texas
    Dallas, Texas 75235, United States
    • Amanda Study Coordinator · Contact · aharvey@derm-texas.com · 214-845-6426
    • Kelly Warren, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07105254
Lead sponsor
Derm Texas, PLLC
Collaborators
Arcutis Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 5, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
May 15, 2026 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
Aug 8, 2025

Study contacts

Amanda Harvey, Study Coordinator
Contact
aharvey@derm-texas.com
2148456426
Kelly Warren, MD
principal investigator · Derm Texas, PLLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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