Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07437560
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-65 years able to provide informed consent.
* Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \>=6 months prior to screening.
* Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry.
* Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.
* For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose.
Exclusion Criteria:
* Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.
* Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug/class).
* Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.
* Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.
* History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.
* Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure.
* Pregnant or breastfeeding.
* Known hypersensitivity to study product components.
* Participation in another interventional clinical trial within 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07437560
Study Brief:
Protocol Section:
NCT07437560