NCT00785148已完成3 期
Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).
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
- 31
- 试验地点
- 1
- 主要终点
- The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
研究概览
简要总结
To prove the safety of the gynaecological formulation in normal conditions of use.
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
- 10 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Integral skin test in the region,
- •Use of cosmetic product of the same category
排除标准
- •Lactation or gestational risk or gestation
- •Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
- •Atopic antecedent or allergic to cosmetic product
- •Active cutaneous disease in the evaluation area
- •Diseases which cause immunology decrease, such as diabetes and HIV
- •Endocrinal pathologies
- •Intense solar exposure 15 days before the evaluation
- •Treatment until four months before the selection
- •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
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)
干预措施: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) (Drug)
结局指标
主要结局
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
时间窗: From treatment start to the end of study
次要结局
未报告次要终点
研究者
研究点 (1)
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