To test the cosmetic safety by assessing the skin irritation and allergic potential by using repeated patch test in healthy male and female human adult subjects

Not Applicable

Completed

• Registration Number: CTRI/2022/01/039387
• Lead Sponsor: Vishal Mega Mart Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-17
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects in age group 18 - 55 years (both the ages inclusive).

2. Healthy male and female subjects.

3. Subjects with Fitzpatrick skin type III to V

4. Subjects willing to give a 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 one month.

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

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

Exclusion Criteria

1. Infection, allergy on the tested area.

2. Skin allergy, antecedents or atopic subjects.

3. Athletes and subjects with history of excessive sweating.

4. Cutaneous disease which may influence the study result.

5. Subject has used topical corticosteroids, topical immuno-modulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment

6. Subjects participating in any other cosmetic or therapeutic study.

7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified