To check Safety of the products

Not Applicable

Completed

• Registration Number: CTRI/2023/05/052321
• Lead Sponsor: ITC Life Sciences & Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-05-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Subjects in age group 18 - 65 years (both the ages inclusive).

2. Healthy male & female subjects with skin types as defined in the population details under appendix

3. Subjects with Fitzpatrick skin type III to V

4. 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.

5. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.

6. Subjects willing to give a voluntary written informed consent.

7. Subjects willing to maintain the patch test in position for 24 hours.

8. Subject having not participated in a similar investigation in the past two weeks.

9. Subjects willing to come for regular follow up visits.

10. Subjects ready to follow instructions during the study period.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: Approximately 9 days for each subject.

Secondary Outcome Measures

Name	Time	Method
oneTimepoint: NA