NCT00663390已完成3 期
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events and their intensity and their association with the treatment.
研究概览
简要总结
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 test in the region;
排除标准
- •Lactation or gestational risk or gestation;
- •Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
- •Topical medication use at the region to be treated;
- •Cutaneous disease or active gynecological 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
I
Experimental
干预措施: Lactic acid (Dermacid) (Drug)
结局指标
主要结局
Adverse events and their intensity and their association with the treatment.
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
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