NCT00712868已完成4 期
Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 559
- 试验地点
- 1
- 主要终点
- Clinical and local tolerability
研究概览
简要总结
To demonstrate the safety and acceptability of the gynaecological formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Integral skin in the tested region
排除标准
- •Pregnancy or breastfeeding women
- •Use of anti-inflammatory or immune-suppression drugs
- •Topical medication use at the tested region
- •Active cutaneous gynaecological disease which may interfere in study results
- •Personal history of allergic disease at the area to be treated
- •Allergic or atopic history
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Lactic Acid once a day during 21 days
干预措施: Lactic acid (Drug)
结局指标
主要结局
Clinical and local tolerability
时间窗: After 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
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