A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

What Was Tested

This registered phase 3 trial tested Melanotan I.

It had two arms (groups): Afamelanotide and NB-UVB Light (experimental) and NB-UVB Light (other).

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 200 planned participants were the target.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1. Stable or active vitiligo. Aged 12 or more. Fitzpatrick skin types III-VI.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: fitzpatrick skin types i-ii; extensive leukotrichia; treatment with nb-uvb phototherapy in the last three months prior to study start.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Melanotan I study did not mask who received what.

It started in 2023-10-11 with completion listed for 2025-12.

It ran at 30 sites in United States (25), France (2), United Kingdom (2) and Kenya (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of patients achieving T-VASI 50 on the body (time frame: From baseline to Day 140).

It also tracked 9 secondary outcomes, for example Time to onset of repigmentation of full body, Time to onset of repigmentation of face, Percentage of patients achieving VASI 50 on the face, Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet, Percentage of patients maintaining VASI 50 on facial lesions and Percentage of patients achieving VASI 25/75/90 on the body.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Melanotan I in 200 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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