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

What Was Tested

The trial (phase 2) is built around Melanotan II.

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.

It had two arms (groups): Melanotan II + NB-UVB phototherapy (experimental) and Placebo + NB-UVB phototherapy (placebo comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

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).

Participants are randomized 1:1 and treated for 24 weeks, with standardized digital photography, clinician-rated scoring, and objective colorimetry performed at prespecified visits.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Melanotan II and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Melanotan II, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-02-02 with completion listed for 2027-02-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in Vitiligo Area Scoring Index (VASI) total score (time frame: 24 Weeks).

It also tracked 1 secondary outcome, for example Proportion of participants achieving.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Melanotan II in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Melanotan II compound page, all human trials.