CTRI/2018/03/012474已完成未知
Evaluation of dermatological safety if investigational products by primary irritation patch test on healthy human volunteers of varied skin types
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.Healthy male and female subjects in the age group of 18 - 55 years
- •2.Subjects with Fitzpatrick skin type III to V.
- •3.Subjects willing to give a voluntary written informed consent.
- •4.Subjects willing to maintain the patch test in position for 24 hours.
- •5.Subject having not participated in a similar investigation in the past two weeks.
- •6.Subjects willing to come for regular follow up visits.
- •7.Subjects ready to follow instructions during the study period.
- •8.Subjects without any open wounds, cuts, abrasions, irritation symptoms
排除标准
- •1.Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.
- •2.Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.
- •3.Athletes and subjects with history of excessive sweating.
- •4.Subjects on oral corticosteroid.
- •5.Subjects participating in any other cosmetic or therapeutic trial.
- •6.Subjects with 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
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