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临床试验/CTRI/2022/05/042600
CTRI/2022/05/042600已完成未知

Evaluation of dermatological safety by 24hrs patch test under complete occlusion on healthy human subjects

ASCLEPIUS WELLNESS PVT LTD0 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 and 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. Willingness to avoid to contact water during course of study.
  • 7. Subject having not participated in a similar investigation in the past one month.
  • 8. Subjects willing to come for regular follow up visits.
  • 9. Subjects ready to follow instructions during the study period.
  • 10. Willingness to avoid intense UV exposure on test site ( sun or artificial UV), during the
  • course of the study.

排除标准

  • 1. Subjects having known hypersensitivity to the study product or its constituents.
  • 2. Subjects having clinically significant active dermatitis or skin disease(s) anywhere in
  • 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.
  • 8. Pregnant and lactating females.

研究者

发起方
ASCLEPIUS WELLNESS PVT LTD

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