Efficacy of Melanil in the Treatment of Melasma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
研究概览
简要总结
The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.
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
- •Clinical diagnosis of Melasma
- •Fitzpatrick's skin types I to IV
- •Signed informed consent
- •Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).
排除标准
- •Fitzpatrick's skin types V and VI
- •Treatment with steroids within the duration of the clinical trial.
- •Oral contraception within the duration of the clinical trial
- •Usage of other cosmetics within the duration of the clinical trial
- •Treatment with Clofazimine within the duration of the clinical trial
结局指标
主要结局
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
时间窗: 52 weeks
次要结局
- Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.(52 weeks)
- Photographs, at the beginning of the study and at weeks 8, 12 and 52.(52 weeks)