Melanotan II (MT-II) plus narrowband UV-B to improve repigmentation in stable nonsegmental vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruxolitinib cream for children 6 to under 12 with nonsegmental vitiligo

  This will test whether ruxolitinib cream can safely produce skin repigmentation in children aged 6 to under 12 with nonsegmental vitiligo.

  Recruiting at 78 sites Phase 3 Incyte Corporation · Buenos Aires and 77 other locations · NCT06804811

• Evaluating Ruxolitinib Cream for Children with Nonsegmental Vitiligo

  This study is testing if ruxolitinib cream can help children with nonsegmental vitiligo regain skin color better than a regular cream.

  Recruiting at 83 sites Phase 3 Incyte Corporation · Birmingham, Alabama and 97 other locations · NCT06548360

• crisaborole 2% versus tacrolimus 0.1% with light therapy for facial vitiligo

  This study tests whether applying crisaborole 2% ointment can improve stable facial vitiligo in children and adults and whether it is as safe and effective as tacrolimus 0.1% when combined with light therapy.

  Recruiting Phase 3 Cairo University · Cairo · NCT07904910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.