CTRI/2023/09/057621已完成1 期
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects of varied skin types. - 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
- 1 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
- •1. Subjects with Fitzpatrick skin type III to V
- •2. 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.
- •3. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •4. Subjects willing to give a voluntary 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.
排除标准
- •1. Subjects with infection, allergy on the tested area.
- •2. Subjects with skin allergy, antecedents or atopic subjects.
- •3. Athletes and subjects with history of excessive sweating.
- •4. Subjects with cutaneous disease which may influence the study result.
- •5. Subjects on oral corticosteroid.
- •6. Subjects participating in any other cosmetic or therapeutic trial.
- •7. Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •8. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •9. More than one subject selected/ participating from one family/ household.
- •10. Subjects working with MSCR
研究者
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