Safety test for the test products by patch test method for 24 hours under complete occlusion on healthy human subjects
- Registration Number
- CTRI/2024/05/068029
- Lead Sponsor
- Innovantase research and development services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Subjects in age group 18 - 65 years (both the ages inclusive).
Healthy male & female subjects with skin types as defined in the population details under appendix 1.
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.
Subject able to read, understand and sign an appropriate informed consent form indicating their willingness to participate.
Subjects willing to maintain the patch test in position for 24 hours.
Subjects willing to come for regular follow-up visits.
Subjects ready to follow instructions during the study period.
Subjects with infection or any skin indications at the test area i.e. back of the subjects.
Subjects with known history of skin allergy, antecedents or atopic subjects.
Athletes and subjects with history of excessive sweating.
Subjects with cutaneous disease which may influence the study result.
Subjects on oral corticosteroid.
Subjects participating in any other cosmetic or therapeutic trial.
Subjects who are pregnant or nursing (self-declared).
Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Subjects working with MSCR.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method