CTRI/2016/10/007387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
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
- Interventional
入排标准
入选标准
- •Subjects in age group 18 - 55 years (both the ages inclusive).
- •Healthy male & female subjects.
- •Subjects with Fitzpatrick skin type III to V.
- •Subjects willing to give a voluntary written informed consent.
- •Subjects willing to maintain the patch test in position for 24 hours.
- •Subject having not participated in a similar investigation in the past two weeks.
- •Subjects willing to come for regular follow up visits.
- •Subjects ready to follow instructions during the study period.
- •Subjects with sensitive skin type as per the score obtained from the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.
排除标准
- •Infection, allergy on the tested area.
- •Skin allergy antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid.
- •Subjects participating in any other cosmetic or therapeutic study.
- •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
相似试验
已完成
不适用
To understand the safety of investigational products by assessing the irritation after patch application on human volunteers.CTRI/2012/06/002724ITC RD Centre24
已完成
不适用
Safety testing of cosmetic products by patch testCTRI/2017/05/008582ITC Limited ITC Life Sciences Technology Centre35
已完成
Unknown
To check the test products safetyCTRI/2024/02/062575Transformative Learning Solutions Pvt Ltd24
已完成
不适用
Safety assessment of products on skiCTRI/2019/03/018068ITC Life Sciences Technology Centre24
已完成
2 期
Skin Safety Study on Healthy Human SubjectsCTRI/2017/02/007849Dabur India Limited
