Scenesse® Phase 1 Trial Results Published (afamelanotide) The multi-center, randomized trial ran for a six-month period and involved 55 vitiligo patients, all of whom received NB-UV-B phototherapy and half who also received Scenesse® (afamelanotide) in addition to the phototherapy. Everyone had statistically significant improvement, but results for those who received the combination therapy were superior.
Scenesse® was administered via a subcutaneous dissolving implant about the size of a grain of rice. Repigmentation was determined by two scoring systems: the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF) score. Improvement for both groups of patients was seen early in the trial according to both scoring systems, but statistically significant improvement for the patients on the combination therapy came earlier and was more marked. By the end of the trial, those on Scenesse® plus phototherapy showed much greater improvement.
The combination therapy resulted in much greater repigmentation on the face and upper extremities, and results were seen, on average, 20 days earlier than in those on NB-UVB phototherapy alone. Both groups of patients generated both follicular (around the hair follicle) and peripheral (marginal) pigmentation patterns. The study did not test patients on Scenesse® alone, although the authors note that this should be studied in the future. The study also did not test the therapy in lighter-skinned patients, but in the darker-skinned patients who participated, results were most marked in those with the darkest skin.
Scenesse® acts similarly to a natural protein that is important in stimulating melanocyte production and proliferation. Clinuvel Pharmaceutical, the maker of Scenesse®, sponsored the study.
If you’d like to listen to a podcast interview I did with Lachlan Hay about Scenesse® CLICK HERE