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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
研究概览
简要总结
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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)
干预措施: Afamelanotide (Drug)
Arm B: NB-UVB alone
Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)
干预措施: NB-UVB (Device)
结局指标
主要结局
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
时间窗: 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
次要结局
- Maintenance of pigmentation achieved(6 months)