NCT00668460已完成3 期
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Delicata Pocket BR.
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
- 52
- 试验地点
- 1
- 主要终点
- The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
研究概览
简要总结
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.
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
- •Phototype Skin I,II, III e IV
- •Integral skin test in the region
排除标准
- •Lactation or gestation
- •Use of Antiinflammatory and/or immunosuppression drugs
- •Personnel history of atopy
- •History of sensitivity or irritation for topic products
- •Active cutaneous disease
- •Use of new drugs or cosmetics during the study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
时间窗: six weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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