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

What Was Tested

This registered phase 2 trial tested Melanotan I.

It had three arms (groups): Afamelanotide and NB-UVB (experimental), Placebo and NB-UVB (placebo comparator) and Single-Arm, Open Label Group (experimental).

Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

Participants received Placebo implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

The study design was modified into a single-arm, open label study with only one treatment group receiving afamelanotide implants plus NB-UVB light. Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

The registry classes the interventions as drug.

More on the Plan

Vitiligo is the most common depigmentation disorder.

A commonly used treatment is phototherapy with narrow-band ultraviolet B 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

Enrollment: 21 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Vitiligo involving the head and neck. Stable or slowly progressive vitiligo over a 3-month period. Aged 21 years or more. Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator. Provided written Informed Consent prior to the performance of any study-specific procedure.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: extensive leukotrichia, in the opinion of the investigator; previous treatment with nb-uvb light or other light source within 6 weeks prior to the screening visit; previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the screening visit.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Melanotan I and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-06-06 with completion listed for 2016-02-02.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) (time frame: From Day 0 to Day 196).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Melanotan I in 21 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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