CTRI/2018/02/012205已完成未知
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type. - NI
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.Subjects in age group 18 - 55 years (both the ages inclusive).
- •2.Healthy male & 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.Subject having not participated in a similar investigation in the past two weeks.
- •7.Subjects willing to come for regular follow up visits.
- •8.Subjects ready to follow instructions during the study period.
- •9.Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I (As per protocol)and by dermatological evaluation for the confirmation of the same.
排除标准
- •1.Infection, allergy on the tested area.
- •2.Skin allergy antecedents or atopic subjects.
- •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.
研究者
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