Prevention of Melasma Relapse During Summertime
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Comparison between MASI scores before prevention treatment and after 6 months
研究概览
简要总结
Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.
详细描述
40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).
There will be 3 visits: Baseline, T2.5months and T5months (final visit).
Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.
Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Other pigmentary disorders associated (including PIH)
结局指标
主要结局
Comparison between MASI scores before prevention treatment and after 6 months
时间窗: 6 months
MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period
次要结局
未报告次要终点