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临床试验/CTRI/2018/02/012205
CTRI/2018/02/012205已完成未知

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type. - NI

ITC Life Sciences 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.Subjects in age group 18 - 55 years (both the ages inclusive).
  • 2.Healthy male & female subjects.
  • 3.Subjects with Fitzpatrick skin type III to V.
  • 4.Subjects willing to give a written informed consent.
  • 5.Subjects willing to maintain the patch test in position for 24 hours.
  • 6.Subject having not participated in a similar investigation in the past two weeks.
  • 7.Subjects willing to come for regular follow up visits.
  • 8.Subjects ready to follow instructions during the study period.
  • 9.Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I (As per protocol)and by dermatological evaluation for the confirmation of the same.

排除标准

  • 1.Infection, allergy on the tested area.
  • 2.Skin allergy antecedents or atopic subjects.
  • 3.Athletes and subjects with history of excessive sweating.
  • 4.Cutaneous disease which may influence the study result.
  • 5.Subjects on oral corticosteroid
  • 6.Subjects participating in any other cosmetic or therapeutic study.
  • 7.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 Technology Centre

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