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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable)

In brief

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.

Key facts

Study ID

NCT07437560

Run by

Hudson Biotech

People needed

60

Starts

2026-02-02

Expected to finish

2028-02-17

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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