Primary Irritation Patch Testing on Adult Healthy Human Subjects with Sensitive Skin. (Single 24-Hour Application)
- Registration Number
- CTRI/2022/11/046975
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
1)Subjects with Fitzpatrick skin type III to V
2)Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females).
3)Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire.
4)Subjects identified to have sensitive skin on the basis of Dermatological assessment of skin with fine texture and closeness of blood vessels to the surface.
1)Subjects who are pregnant or nursing (as confirmed by Urine Pregnancy Test for the determination of Pregnancy).
2)Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study.
3)Subjects with cutaneous disease, chronic illness or self-reported Immunological disorders or any other illness including Diabetes, liver disease, HIV or any other serious medical illness.
4)Subject suffering from any active clinically significant skin diseases which may contraindicate.
5)Subjects with known allergy or sensitization to medical adhesives, bandages or a present condition of allergic response to any cosmetic product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritation Potential of test productsTimepoint: 24 hours post patch removal (Day 03)
- Secondary Outcome Measures
Name Time Method Irritation Potential of test productsTimepoint: 30 minutes post patch removal (Day 02) and 168 hours post patch removal (Day 09);Irritation potential of the test products by Subject Self-assessment (Irritation)Timepoint: Day 01, Day 02, Day 03 & Day 09;Safety by asking well-being of subject and Adverse Event assessmentTimepoint: Day 02, Day 03 & Day 09