Melanotan II (MT-II) plus narrowband UV-B to improve 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
This Phase 2 test will see if adding Melanotan II (MT-II) to standard narrowband UV-B phototherapy helps adults with stable nonsegmental vitiligo regain skin pigment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hudson Biotech Industry-sponsored |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07437560 on ClinicalTrials.gov |
What this trial studies
This randomized, double-arm Phase 2 trial enrolls adults with stable nonsegmental vitiligo and randomizes them 1:1 to receive investigational MT-II or placebo alongside standardized narrowband UV-B (NB-UVB) phototherapy for 24 weeks. Repigmentation is measured using standardized digital photography, clinician-rated scoring, and objective colorimetry at prespecified visits. Safety monitoring includes adverse event collection, vital signs, focused skin exams with nevi surveillance, and a follow-up safety visit 4 weeks after the last dose. The goal is to gather preliminary safety and efficacy data to inform larger studies.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with clinically diagnosed stable nonsegmental vitiligo (no new lesions or expansion for ≥6 months), 3–20% body surface area involvement, and at least two measurable target lesions who can commit to NB-UVB and study visits.
Not a fit: Patients with predominantly segmental or actively progressing vitiligo, recent systemic immunosuppressive or JAK inhibitor use within protocol windows, children, or those unable to attend the Shenzhen site are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, adding MT-II could lead to faster or greater repigmentation for adults with stable nonsegmental vitiligo when combined with NB-UVB.
How similar studies have performed: Narrowband UV-B is an established repigmentation therapy, but combining it with melanocortin receptor agonists like MT-II is a relatively novel and still experimentally tested approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenzhen, Guangdong
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Seni S Lu, Phd
- Email: Seni-Lu@beijing-biotech.com
- Phone: +86 13076790030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.