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)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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)

Quick Facts

Study Start:2025-08-01

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07105254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Amanda Harvey, Study Coordinator

CONTACT

2148456426

aharvey@derm-texas.com

Principal Investigator

Kelly Warren, MD

PRINCIPAL_INVESTIGATOR

Derm Texas, PLLC

Study Locations (Sites)

Derm Texas

Dallas, Texas, 75235

United States

Collaborators and Investigators

Sponsor: Derm Texas, PLLC

Kelly Warren, MD, PRINCIPAL_INVESTIGATOR, Derm Texas, PLLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2026-06-15

Terms related to this study

Additional Relevant MeSH Terms

Non-segmental Vitiligo