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.
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). The earliest described function of alpha-MSH is its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation Other Name: CUV1647
To be administered 3 times/week for 6 months. 72 treatments in total.
Henry Ford Medical Center
Detroit, Michigan, United States
The Mount Sinai School of Medicine
New York, New York, United States
Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores
Time frame: 6 months
Time to onset of repigmentation of full body, face, trunk and extremities
Time frame: 6 months
Quality of life using the Dermatology Life Quality Index (DLQI)
Time frame: 6 months
Vitiligo biopsies assessments (optional, selected sites only)
Time frame: 6 months
Short term safety of both treatments: Routine laboratory assessments - Full body anterior and posterior photography - Vitiligo lesion photography - Examination of the skin and oral mucosa and digital photography - Ophthalmologic examination
Time frame: 6 months
Maintenance of pigmentation using the VASI and VETF scores
Time frame: 12 months
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