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临床试验/CTRI/2017/02/007875
CTRI/2017/02/007875已完成未知

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types

ITC Life Sciences and Technology Centre0 个研究点目标入组 24 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Healthy male and female subjects in the age group of 18 - 55 years (both the ages
  • inclusive).
  • 2. Subjects with Fitzpatrick skin type III to V.
  • 3. Subjects willing to give a voluntary written informed consent.
  • 4. Subjects willing to maintain the patch test in position for 24 hours.
  • 5.Subject having not participated in a similar investigation in the past two weeks.
  • 6. Subjects willing to come for regular follow up visits.
  • 7. Subjects ready to follow instructions during the study period.
  • 8. Subjects without any open wounds, cuts, abrasions, irritation symptoms

排除标准

  • ââ?¬Â¢ Subjects with Infection/ allergy/ irritation symptoms on the upper back area
  • identified for patch application.
  • ââ?¬Â¢ Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease
  • which may influence the study results.
  • ââ?¬Â¢ Athletes and subjects with history of excessive sweating.
  • ââ?¬Â¢ Subjects on oral corticosteroid.
  • ââ?¬Â¢ Subjects participating in any other cosmetic or therapeutic trial.
  • ââ?¬Â¢ Subjects with any history of underlying uncontrolled medical illness including
  • diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

研究者

发起方
ITC Life Sciences and Technology Centre

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