๐ฌIn plain words
What the trial is, and whether it could suit you
This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.