Evaluation of Dermatological safety of Investigational products by primary irritation patch test onhealthy human volunteers of varied skin types

ITC Life Sciences Technology Centre0 sites24 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 26, 2019

Last Updated

3 years ago

Study Type

Interventional

Sponsor

ITC Life Sciences Technology Centre

•1\. Healthy male and female subjects in the age group of 18\-55 years(both age inclusive)
•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 test patches in designated positions for 24 Hours
•5\. Subjects 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\. Subject is Pregnant or Lactating
•4\. Athletes and subjects with history of excessive sweating
•5\. Subjects on oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results
•6\. Subjects participating in any other cosmetic or therapeutic trial
•7\. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness