A Single Blind, Balanced, Clinical Trial To Evaluate The Dermatological Safety of Investigational Products By Primary Irritation Patch Test Potential on Healthy Adult Human Subjects WithSensitive Skin (Single 24-Hour Application).

Apex Laboratories Private Limited0 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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•Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
•Subjects who have sensitive skin determined by the Dermatologist on basis of skin sensitivity questionnaires during screening visit.
•Subjects with positive reaction to lactic acid stinging test.
•Subjects who do not have any previous history of adverse skin conditions and are not under any medication.
•Subject with good general health as determined by the Investigator on the basis of medical history.
•Subjects willing to maintain the test patches in designated position for 24 hours.
•Subjects with Fitzpatrick skin type III to V.
•Subjects willing to give a voluntary written informed consent.
•Subject having not participated in a similar investigation in the
•past two weeks.
•Subjects without any open wounds, cuts, abrasions, irritation symptoms.

•Female subject is pregnant, planning for pergnancy or lactating.
•Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimple marks, open wounds, sunburn, scars, tattoos, cuts, irritation symptoms.
•Medication which may affect skin response and/or past medical history.
•Subjects having history of diabetes.
•Subject suffering from any active clinically significant skin diseases which may contraindicate.
•Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
•Subjects having history of asthma or COPD (Chronic obstructivepulmonary disease).
•Subject with known allergy or sensitization to medical adhesives, bandages.
•Athletes and subjects with history of excessive sweating.
•Cutaneous disease which may influence the study result.
•Participation in other patch study simultaneously.

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