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Tests treatment safety and results for Non-segmental Vitiligo
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
What this study is testing
What is Roflumilast topical 0.3% foam?
Roflumilast topical 0.3% foam is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for non-segmental vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Male or female people aged 2 years but less than 18 years
- Pediatric and adolescent people: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the people, as required by local...
- 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
You likely can't join if
- people with any serious medical condition or physical examination abnormality that would prevent study participation or place the subject at...
- people with known or suspected:
- Severe renal insufficiency
- Moderate to severe hepatic disorders (Child-Pugh B or C)
- people who cannot discontinue prohibited medications and treatments prior to the Baseline visit and during the study, including (any biologic or...
- people 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...
See the full eligibility criteria
- Male or female people aged 2 years but less than 18 years
- Pediatric and adolescent people: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the people, 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
- 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.
- people 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.
- people 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.
- people with known or suspected:
- Severe renal insufficiency
- Moderate to severe hepatic disorders (Child-Pugh B or C)
- people 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...
- people 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.
- people 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...
- people 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...
- people who cannot discontinue systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g. Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine)
- people 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). people who are unable to communicate, read or understand the local language, or who display another condition...
- people who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled people living in the same house.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.