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

What Was Tested

This registered phase 1 trial tested Melanotan I.

It had two arms (groups): Afamelanotide + NB-UVB: Experimental (experimental) and NB-UVB alone: Active Comparator (active comparator).

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).

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

The registry classes the interventions as drug and procedure.

More on the Plan

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).

Further therapeutic approaches are desired and currently being evaluated.

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

Who Took Part

56 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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 24 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

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Melanotan I group and the comparison group should start out alike.

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 2011-06 with completion listed for 2012-05.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores (time frame: 6 months).

It also tracked 5 secondary outcomes, for example Time to onset of repigmentation of full body, face, trunk and extremities, Quality of life using the Dermatology Life Quality Index (DLQI), Vitiligo biopsies assessments (optional, selected sites only) and Maintenance of pigmentation using the VASI and VETF scores.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Melanotan I in 56 people.

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.