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临床试验/CTRI/2023/06/054177
CTRI/2023/06/054177已完成1 期

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects of varied skin types. - 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
1 期
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 & female subjects with skin types as defined in the population details
  • under appendix.
  • 2. Subjects with Fitzpatrick skin type III to V
  • 3. Subjects in good health condition as per the medical screening criteria with no
  • disease state or physical condition that the Investigator believes could
  • interfere with the interpretation of the data.
  • 4. Subject able to read, understand and sign an appropriate informed consent
  • form indicating her willingness to participate.
  • 5. Subjects willing to give a voluntary written informed consent.
  • 6. Subjects willing to maintain the patch test in position for 24 hours.
  • 7. Subject having not participated in a similar investigation in the past two weeks.
  • 8. Subjects willing to come for regular follow up visits.
  • 9. Subjects ready to follow instructions during the study period.

排除标准

  • 1. Subjects with infection, allergy on the tested area.
  • 2. Subjects with skin allergy, antecedents or atopic subjects.
  • 3. Athletes and subjects with history of excessive sweating.
  • 4. Subjects with cutaneous disease which may influence the study result.
  • 5. Subjects on oral corticosteroid.
  • 6. Subjects participating in any other cosmetic or therapeutic trial.
  • 7. Subjects who are currently pregnant or lactating or planning to become
  • pregnant in the period of study.
  • 8. Subjects with any history of underlying uncontrolled medical illness including
  • diabetes, liver disease or history of alcoholism, HIV or any other serious
  • medical illness.
  • 9. More than one subject selected/ participating from one family/ household.
  • 10. Subjects working with MSCR

研究者

发起方
ITC Life Sciences & Technology Centre

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