Safety testing of cosmetic products by patch test

Not Applicable

Completed

• Registration Number: CTRI/2017/05/008582
• Lead Sponsor: ITC Limited ITC Life Sciences Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-19
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Healthy male and female subjects in the age group of 18-55 years (both age inclusive)

2. Subjects in good general health

3. Subjects with Fitzpatrick skin type III to V

4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannââ?¬•s skin type questionnaire

5.Subject identified to have sensitive skin basis dermatologistââ?¬•s assessment of skin with fine texture and closeness of blood vessels to the surface

6.Subjects willing to give a voluntary written informed consent

7. Subjects willing to maintain the test patches in designated positions for 24 hours

8. Subjects having not participated in a similar investigation in the past eight weeks

9. Subjects willing to come for regular follow up visits

10. Subjects ready to follow instructions during the study period

11. Subjects without any open wounds, cuts, abrasions, irritation symptoms

Exclusion Criteria

1. Subjects with a present condition of allergic response to any cosmetic product

2. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study

3. Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy)

4. Subjects with cutaneous disease that could interfere with the study results

5. Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness

6. Subjects participating in any other cosmetic or therapeutic trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified