CTRI/2024/05/068029已完成2 期
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects - NI
Innovantase research and development services0 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
- 2 期
- 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
- •Subjects in age group 18 - 65 years (both the ages inclusive).
- •Healthy male & female subjects with skin types as defined in the population details under appendix 1.
- •Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •Subject able to read, understand and sign an appropriate informed consent form indicating their willingness to participate.
- •Subjects willing to maintain the patch test in position for 24 hours.
- •Subjects willing to come for regular follow-up visits.
- •Subjects ready to follow instructions during the study period.
排除标准
- •Subjects with infection or any skin indications at the test area i.e. back of the subjects.
- •Subjects with known history of skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Subjects with cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid.
- •Subjects participating in any other cosmetic or therapeutic trial.
- •Subjects who are pregnant or nursing (self-declared).
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •Subjects working with MSCR.
研究者
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