Safety testing for cosmetic products

Not Applicable

Completed

• Registration Number: CTRI/2017/12/011010
• Lead Sponsor: KAMA Ayurveda Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-03
• Last Update Posted: 24 November 2021

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 symptomson the upper back

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