Safety testing of cosmetic products through patch test

Not Applicable

Completed

• Registration Number: CTRI/2017/08/009503
• 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: 2017-09-12
• 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 in good general health

3)Subjects with Fitzpatrick skin phototype 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 willing to come for regular follow up visits

9)Subjects ready to follow instructions during the study period

10) Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results

Exclusion Criteria

1) Subjects with a present condition of allergic response to any cosmetic product on the test area

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 suffering from any cutaneous disease that could interfere with the study

results

5) Subjects suffering from any 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

7) Subjects having participated in a similar investigation in the past four weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified