Non-segmental VitiligoPhase 2NCT07105254
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 study testing Roflumilast topical 0.3% foam in people with Non-segmental Vitiligo, run by Derm Texas, PLLC at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- Roflumilast topical 0.3% foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 15 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects aged 2 years but less than 18 years
- 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.
- Diagnosis of non-segmental vitiligo based on clinical history and dermatology examination for at least 3 months.
- Diagnosis of non-segmental vitiligo with the following:
- BSA affected < 10% AND
- At least 0.5% BSA affected on the face. AND
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- Pigmented hair within some of the areas of vitiligo on the face
- In good health as judged by the Investigator, based on the medical history, and dermatology examination.
- 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.
Who cannot join
- 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.
- Subjects with known or suspected:
- Severe renal insufficiency
- Moderate to severe hepatic disorders (Child-Pugh B or C)
- 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.
- 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.
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- 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.
- Subjects with known genetic dermatological conditions that overlap with non-segmental vitiligo.
- 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)
- Subjects who cannot discontinue systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g. Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine)
- Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/Day 1.
- Females who are pregnant, wishing to become pregnant during the study, or are breast feeding.
- Previous treatment with Roflumilast cream or foam for vitiligo in the past 3 months.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Derm Texas
Dallas, Texas, 75235
Amanda Study Coordinator, 214-845-6426, aharvey@derm-texas.com
Kelly Warren, MD
About this study
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)
- Conditions
- Non-segmental Vitiligo
- Being tested
- Roflumilast topical 0.3% foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast topical 0.3% foamDrug
Roflumilast 0.3% topical foam
| Study group | Role | What they receive |
|---|---|---|
| Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% | Experimental | Not described Receives: Drug: Roflumilast topical 0.3% foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, the at weeks 4, 8, 12, 18 & 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derm Texas, PLLC
- Sponsor type
- Research network
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Kelly Warren, MD, Principal investigator, Derm Texas, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105254
- Sponsor's protocol ID
- 20251829
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07105254
- Acronym / sponsor ID
- 20251829
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Derm Texas, PLLCResearch network
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% | Experimental | Drug: Roflumilast topical 0.3% foam |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male or female subjects aged 2 years but less than 18 years
- 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.
- Diagnosis of non-segmental vitiligo based on clinical history and dermatology examination for at least 3 months.
- Diagnosis of non-segmental vitiligo with the following:
- In good health as judged by the Investigator, based on the medical history, and dermatology examination.
Key exclusion criteria (15 listed)
- 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.
- Subjects with known or suspected:
- 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.
- 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.
- Subjects with known genetic dermatological conditions that overlap with non-segmental vitiligo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast topical 0.3% foamRoflumilast 0.3% topical foam | Drug | Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% |
Primary outcome
The primary endpoint of this study is the number patients achieving F-VASI 50.
Time frame: Week 24
The number of patients achieving a 50% improvement in their facial Vitiligo Area \& Severity Index score (F-VASI 50) at week 24.
1 secondary outcome
- 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)
Time frame: Baseline, the at weeks 4, 8, 12, 18 & 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Warren, MD principal investigator
Derm Texas, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast topical 0.3% foam in people with Non-segmental Vitiligo, run by Derm Texas, PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Harvey, Study Coordinator (2148456426, aharvey@derm-texas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is the number patients achieving F-VASI 50. (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.