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
Overview
- Phase
- Phase 2
- Intervention
- Afamelanotide
- Conditions
- Vitiligo
- Sponsor
- Clinuvel Pharmaceuticals Limited
- Enrollment
- 15
- Primary Endpoint
- To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A: Afamelanotide + NB-UVB
Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)
Intervention: Afamelanotide
Arm B: NB-UVB alone
Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)
Intervention: NB-UVB
Outcomes
Primary Outcomes
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
Time Frame: 6 months
Time to onset of repigmentation of full body, face, trunk and extremities Pigmentation by VASI and VETF Maintenance of pigmentation Dermatology Life Quality Index (DLQI) Safety of the treatment will be assessed by: For selected study sites, immunomodulatory assessment Full body anterior and posterior photography Vitiligo lesion photography Examination of the skin and oral mucosa and digital photography Ophthalmologic examination
Secondary Outcomes
- Maintenance of pigmentation achieved(6 months)