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 sites24 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Sponsor

ITC Life Sciences Technology Centre

•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.

•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