Vitiligo Clinical Trial
Official title:
A Phase II Randomised Pilot Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
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).
The purpose of this study is to look at the efficacy of afamelanotide, when combined with
narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.
Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to
reducing frequency and doses of NB-UVB.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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