Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo

What Was Tested

This registered phase 2 trial tested Melanotan I.

It had two arms (groups): Arm A: Afamelanotide + NB-UVB (experimental) and Arm B: NB-UVB alone (active comparator).

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).

Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).

The registry classes the interventions as device and drug.

More on the Plan

The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH).

The earliest described function of alpha-MSH is its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation.

Vitiligo is the most common depigmentation disorder.

Interventions in the treatment of vitiligo include phototherapy with narrow-band (NB) ultraviolet B (UVB) irradiation (NB-UVB).

Who Took Part

The registry lists 15 actual participants took part.

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. Aged 18 or more. Fitzpatrick skin types III-VI. Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator. Providing written Informed Consent prior to the performance of any study-specific procedure.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: fitzpatrick skin types i-ii; vitiligo involving the hands and feet only; extensive leukotrichia, in the opinion of the investigator.

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.

The Melanotan I group and the comparison group ran side by side rather than switching.

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

It started in 2011-09 with completion listed for 2012-07.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Maintenance of pigmentation achieved.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Melanotan I in 15 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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