Three Vitiligo Patients Show Significant Repigmentation After SCENESSE® Treatment

New Hope for Vitiligo Patients

CLINUVEL Pharmaceuticals has shared encouraging data from its ongoing CUV105 study, presenting three new vitiligo patient cases at the European Academy of Dermatology and Venereology (EADV) conference in Paris. The patients, treated at a reference hospital in La Reunion, France, received a combination of SCENESSE® (afamelanotide 16mg) implants and narrowband ultraviolet B (NB-UVB) phototherapy sessions, resulting in significant repigmentation of affected skin areas.

Vitiligo, a chronic condition characterised by loss of skin pigmentation, has long posed a therapeutic challenge. The cases presented involved patients with Fitzpatrick skin types IV and V, who had experienced long-standing disease and, in some instances, resistance or relapse following conventional topical treatments. The new data highlight not only the extent of repigmentation but also its stability, with follow-up evaluations conducted 14 weeks after treatment completion.

Treatment Regimen and Patient Outcomes

The treatment protocol involved seven SCENESSE® implants administered over the study period, alongside up to 40 NB-UVB phototherapy sessions. The combination appears to have activated melanocyte function, leading to gradual restoration of pigmentation in vitiligo-affected regions such as the face, groin, and legs. Notably, the darkening of unaffected skin was temporary, returning to baseline within weeks after treatment cessation.

Patients expressed satisfaction with the therapy, and no unexpected safety concerns emerged, reinforcing SCENESSE®'s tolerability profile. Dr Emilie Rodenburger, CLINUVEL’s Director of Global Clinical Affairs, emphasised the importance of patient understanding regarding the temporary skin darkening required to trigger repigmentation. She also noted the excitement among treating physicians, who may now have a viable option for patients with extensive vitiligo.

Looking Ahead

While these case studies provide promising early evidence, the full results of the CUV105 study are anticipated in 2026, which will offer a more comprehensive assessment of SCENESSE®'s efficacy and safety in vitiligo treatment. CLINUVEL’s broader expertise in photomedicine and melanocortin peptides positions it well to potentially expand SCENESSE®’s indications beyond its current approvals for erythropoietic protoporphyria.

As the company continues to navigate regulatory pathways and clinical development, these findings may mark a significant step forward in addressing an unmet medical need for vitiligo patients worldwide.