To study the safety of a test product using the patch test technique

Not Applicable

Completed

• Registration Number: CTRI/2021/11/038298
• Lead Sponsor: Mosaic Wellness Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1. Voluntary men and women (preferably equal number of males and females) between 18

and 65 years.

2. Fitzpatrick skin type III to IV.

3. Having apparently healthy skin on test area.

4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application

areas during the course of the trial

5. Cooperating, informed of the need and duration of the examinations, and ready to comply

with protocol procedures.

6. Willing to give written informed consent to participate in the trial after informing all

information concerning the trial procedures and trial objectives.

7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the

course of the trial.

8. Willingness to avoid water contact (swimming) or activity which cause sweating (exercise, sauna�), during the course of the trial.

9. Should be able to read and write (in English, Hindi, or local language).

Exclusion Criteria

1.Pregnancy (by history) and lactating women.

2.Scars, excessive terminal hair, or tattoo on the studied area.

3. A participant who the Investigator feels will not be compliant with trial requirements

4.Dermatological infection/pathology on the level of studied area.

5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).

6. Any clinically significant systemic or cutaneous disease, which may interfere with trial

procedures.

7. Chronic illness which may influence the outcome of the trial.

8. Participants on any medical treatment either systemic or topical which may interfere with

the performance of the trial (presently or in the past 1 month).

9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified