Recruiting
Phase 2
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
Condition(s) studied
NonSegmental VitiligoNonsegmental Vitiligo (Stable)
Investigational drug(s) / intervention(s)
Melanotan II (MT-II)PlaceboNarrowband UV-B (NB-UVB) phototherapy
Melanotan II (MT-II): administered per protocol
Placebo: matched, administered per protocol.
Narrowband UV-B (NB-UVB) phototherapy: standardized schedule per site protocol
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Change from baseline in Vitiligo Area Scoring Index (VASI) total score — 24 Weeks
Trial sites (1)
| Facility | City | Region | Status |
| Peking University Shenzhen Hospital |
Shenzhen |
Guangdong |
Recruiting |
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