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临床试验/CTRI/2022/01/039477
CTRI/2022/01/039477已完成未知

To assess the mildness of Baby Cosmetic Products marketed by Vishal Mega Mart Pvt. Ltd., using skin irritation test by 24hrs single patch test under complete occlusion on healthy human subjects.

Vishal Mega Mart 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 the 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 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 month.
  • 7. Subjects willing to come for regular follow-up visits.
  • 8. Subjects ready to follow instructions during the study period.

排除标准

  • 1. Infection, allergy on the tested area.
  • 2. Skin allergy, antecedents, or atopic subjects.
  • 3. Athletes and subjects with a history of excessive sweating.
  • 4. Cutaneous disease which may influence the study result.
  • 5. Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
  • 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
Vishal Mega Mart Pvt Ltd

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