CTRI/2012/12/003206已完成未知
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- Observational
入排标准
入选标准
- •1.Subjects age group 18 - 55 years
- •2.Healthy male & female volunteers
- •3.Subjects with 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.Subject has not participated in a similar investigation in the past two weeks.
- •7.Subjects willing to come for regular follow up.
- •8.Subjects ready to follow instructions during the study period.
排除标准
- •1.Infection, allergy on the tested area
- •2.History of skin allergy antecedents or atopic subjects
- •3.History of hyper sensitivity to any component of the tested products
- •4.Athletes and subjects with history of excessive sweating
- •5.Cutaneous disease which may influence the study result
- •6.Chronic illness which may influence the cutaneous state.
- •7.Subjects on oral corticosteroid
- •8.Subjects participating in any other cosmetic or therapeutic trial.
- •9.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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