跳至主要内容
临床试验/NCT00497692
NCT00497692已完成4 期

Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata

Sanofi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年5月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Sanofi
入组人数
30
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 Femina Delicata.

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

  • •Phototypes: I, II, III and IV
  • •Integral skin test in the region

排除标准

  • •Pregnancy or breastfeeding women
  • •Use of antinflammatory or immune-suppression drugs
  • •Personal history of atopy
  • •History of sensibilization or irritation for topic products
  • •Active cutaneous disease
  • •Use of new drugs and/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

Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)

时间窗: six weeks

次要结局

未报告次要终点

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

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