Safety testing of products by Primary Patch Test

Not Applicable

Completed

• Registration Number: CTRI/2019/02/017703
• 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: 2019-02-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified