To check irritation potential of the given samples (Patch test)

Phase 2

Completed

• Registration Number: CTRI/2019/11/022065
• Lead Sponsor: ITC LIMITED ITC Life Sciences and Technology CENTRE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-05
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1.Volunteer (female/ male) in generally good health.

2.Volunteer between the ages of 18 and 65 years.

3. Volunteer has not participated in a similar clinical investigation in the past four weeks.

4. Volunteer willing to give a written informed consent and come for regular observation.

5.Subjects scoring greater than 30 for Section 2- Sensitive Vs Resistant skin in modified Dr. Baumannââ?¬•s sensitive skin Questionnaire.

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

Exclusion Criteria

1. A known history or present condition of allergic response to any cosmetic products.

2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.

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

4.Pregnant or lactating females.

5.Subjects participating in any other cosmetic or therapeutic trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Irritation potentialTimepoint: first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal

Secondary Outcome Measures

Name	Time	Method
investigational products to be tested for irritancy testTimepoint: On each subject�s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).