NCT00705744已完成3 期
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.
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
- 26
- 试验地点
- 1
- 主要终点
- The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
研究概览
简要总结
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 II and III;
- •Integral skin test in the region;
排除标准
- •Lactation or gestation;
- •Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
- •Diseases which can cause immunity decrease, such as HIV, diabetes;
- •Use of drug photosensitizer;
- •History of sensitivity or irritation for topic products;
- •Active cutaneous disease which can change the study results;
- •History or photodermatosis active;
- •Family or personal antecedent of cutaneous photoinduced neoplasias;
- •Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
- •Intense solar exposure in the study area;
- •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.
研究组 & 干预措施
I
Experimental
干预措施: Lactic acid (Dermacyd Femina) (Drug)
结局指标
主要结局
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
时间窗: 5 weeks
The sensibility will be evaluated according to the skin type.
时间窗: 5 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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