Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.

ITC Life Sciences and Technology Centre0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Healthy male and female subjects in the age group of 18 - 55 years
•2. Subjects with Fitzpatrick skin type III to V.
•3. Subjects willing to give a voluntary written informed consent.
•4. Subjects willing to maintain the patch test in position for 24 hours.
•5. Subject having not participated in a similar investigation in the past two weeks.
•6. Subjects willing to come for regular follow up visits.
•7. Subjects ready to follow instructions during the study period.
•8. Subjects without any open wounds, cuts, abrasions, irritation symptoms

•1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.
•2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.
•3. Athletes and subjects with history of excessive sweating.
•4. Subjects on oral corticosteroid.
•5. Subjects participating in any other cosmetic or therapeutic trial.
•6. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

发起方

ITC Life Sciences and Technology Centre