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
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