Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT) - NI

HNL Business Services India Private Limited0 个研究点目标入组 110 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Male or female subjects 18 to 65 years (both inclusive) of age.
•2.Subjects with skin photo type III to V
•3.Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
•4.The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
•5.Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
•6.Subjects must have clear back. They should not have any infection or allergy on the tested area. They should have healthy skin (Healthy skin is smooth, with no breaks in the surface. It is devoid of any rashes, scars, bumps etc.) on test area
•7.Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures
•8.Subjects having valid proof of identity and age.
•9.Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study

•1.Pregnant women/ Nursing mothers
•2.Presence of scars, excessive terminal hair or tattoo on the studied area.
•3.Henna tattoo seen on the test site of the body.
•4.Dermatological infection/pathology on the level of studied area
•5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
•6.Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures, as evaluated by the study PI and co-PI.
•7.Chronic illness which may influence the outcome of the study.
•8.Subject on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
•9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
•10.Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision
•11.Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness

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