Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Melanotan II (Synthetic Cyclic Melanocortin Receptor Agonist) as an Adjunct to Narrowband UV-B Phototherapy in Adults With Stable Nonsegmental Vitiligo
Hudson Biotech
60 participants
Feb 2, 2026
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria9
- 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.
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Interventions
administered per protocol
matched, administered per protocol.
standardized schedule per site protocol
Locations(1)
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NCT07437560