Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) – Full Text View – ClinicalTrials.gov
This study has been completed.
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 (Melanotan) is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.
|Vitiligo||Drug: AfamelanotideProcedure: Narrow-Band UVB Light Treatment||Phase 1|
|Study Design:||Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment|
|Official Title:||Proof of Concept Study to Compare Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Nonsegmental Vitiligo|
U.S. FDA Resources
Primary Outcome Measures:
- Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to onset of repigmentation of full body, face, trunk and extremities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life using the Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Vitiligo biopsies assessments (optional, selected sites only) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Maintenance of pigmentation using the VASI and VETF scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Afamelanotide + NB-UVB: Experimental|
Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).
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
Other Name: CUV1647
|Active Comparator: NB-UVB alone: Active Comparator|
Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).
|Procedure: Narrow-Band UVB Light Treatment|
To be administered 3 times/week for 6 months. 72 treatments in total.
Other Name: NB-UVB light treatment
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430195
|United States, Michigan|
|Henry Ford Medical Center|
|Detroit, Michigan, United States, 48202|
|United States, New York|
|The Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Henry Lim, MD||Henry Ford Hospital, 3031 W. Grand Blvd., Suite 800, Detroit, MI 48202, USA|