Dermatological assessment of primary irritation of stempeucareâ?¢ using patch test technique on skin of adult healthy human volunteers

Stempeutics Research Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Healthy male and female subjects in the ration of 1:1.
•Subjects with skin phototype III to V and Subjects willing to keep the patch in position for 24 hours.
•Subjects willing to come for follow up visit at specified interval for 9 days.
•Subjects ready to follow instructions during the study period.
•Subjects with healthy skin on the studied anatomic unit (free of eczema, wounds and inflammatory scars).
•Subjects representing varied skin types (representation of all 4 skin types â?? oily, normal, dry and combination).

•Subjects having infection, allergy, bruises or scars on the area to be tested.
•Subjects having known hypersensitivity to any component of the tested products.
•Subjects having sensitivity to penicillin, based on history or as confirmed by a sensitivity test on forearm.
•Athletes and subjects with history of excessive sweating.
•Subjects with cutaneous disease that may influence the study result as per investigatorâ??s judgment.
•Subjects having chronic illness that may influence the cutaneous state (for example: SLE) as per investigatorâ??s judgment.
•Subjects on oral corticosteroid therapy.
•Any history of underlying uncontrolled medical illness (including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness) which in the investigatorâ??s opinion will have safety concerns for the subject.
•For females: Being pregnant or breastfeeding or having stopped breastfeeding within the last three months.

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