Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

Registered clinical trial record on ClinicalTrials.gov (NCT07437560). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: recruiting. Study type: interventional. Phase: Phase 2. Sponsor: Hudson Biotech. Conditions: NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable). Interventions: Melanotan II (MT-II), Placebo, Narrowband UV-B (NB-UVB) phototherapy. 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. Vitiligo is characterized by acquired depigmented macules and patches due to the loss of functional melanocytes. Narrowband UV-B (NB-UVB) phototherapy is a common treatment that can promote repigmentation, but responses may be incomplete and can take months. Melanotan II (MT-II) is a synthetic cyclic melanocortin receptor agonist with activity at melanocortin receptors involved in melanogenesis (pigment production). This example trial evaluates the safety and preliminary efficacy of adding investigational MT-II to standardized NB-UVB phototherapy compared with placebo plus NB-UVB in adults with stable nonsegmental vitiligo. Participants are randomized 1:1 and treated for 24 weeks, with standardized digital photography, clinician-rated scoring, and objective colorimetry performed at prespecified visits. Safety monitoring includes adverse event collection, vital signs, and focused skin examinations (including monitoring of nevi). A follow-up visit occurs 4 weeks after the final dose to assess ongoing safety. Primary outcome measures: Change from baseline in Vitiligo Area Scoring Index (VASI) total score. 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.