跳至主要内容
临床试验/NCT00761800
NCT00761800已完成3 期

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .

Sanofi2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2008年5月1日最近更新:
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
51
试验地点
2
主要终点
The absence of primary and accumulated dermal irritability 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 Teen Care Tangerina Mix.

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

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 Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
  • Personal 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 will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.

时间窗: Throughout the study

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 (2)

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