A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face

What Was Tested

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

It had 1 arm (groups): Afamelanotide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 6 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Stable or slowly progressive vitiligo over a 3-month period. Fitzpatrick skin types IV-VI. Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: patients with segmental vitiligo; fitzpatrick skin types i-iii; previous topical treatment for vitiligo.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Melanotan I was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-10-11 with completion listed for 2023-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions (time frame: From Baseline to Day 84).

It also tracked 6 secondary outcomes, for example Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area, Percentage change in pigmentation on body surface area measured by the VASI scoring system, Percentage change in pigmentation on facial surface area measured by the VASI scoring system, Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A), Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B) and Change in Quality of life using a vitiligo specific tool (C).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Melanotan I in 6 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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