NCT00679562已完成2 期
Skin Irritation : Prophetic Patch Test of Lactacyd Radiance
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reaction after patch removal.
研究概览
简要总结
Primay objective:
To evaluate the potential of the products in eliciting adverse skin reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Test area should have a healthy or normal skin
- •Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
- •Not currently use of steroid or any medication during the test
排除标准
- •History of Allergy or Allergic Reaction to:
- •Hey Fever
- •Poison Ivy
- •Cosmetics
- •Detergent
- •Medication
- •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
2
Placebo Comparator
干预措施: Distilled water (Other)
1
Experimental
干预措施: Lactic Acid (Drug)
结局指标
主要结局
Reaction after patch removal.
时间窗: at 15-30 minutes and day 3
次要结局
未报告次要终点
研究者
研究点 (1)
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