NCT00371852已完成3 期
Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes
适应症
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
- 50
- 试验地点
- 1
- 主要终点
- Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)
研究概览
简要总结
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd wipes.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phototypes: I, II, III and IV;
- •Integral skin test in the region;
排除标准
- •Lactation or gestation
- •Use of Anti-inflammatory and/or immune-suppression drugs
- •Personnel history of atopy;
- •History of sensibilization or irritation for topic products;
- •Active cutaneous disease;
- •Use of new drugs and/or cosmetics during the study
结局指标
主要结局
Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)
次要结局
未报告次要终点
研究者
研究点 (1)
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