Dermatological Safety Study on Healthy Human Subjects
- Registration Number
- CTRI/2021/11/038144
- Lead Sponsor
- ADOR MULTIPRODUCTS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Subjects in age group 18 - 55 years (both the ages inclusive).
2. Healthy male and female subjects.
3. Subjects with Fitzpatrick skin type III to V.
4. Subjects willing to give a written informed consent
5. Subjects willing to maintain the patch test in position for 24 hours.
6. Subject having not participated in a similar investigation in the past one months.
7. Subjects willing to come for regular follow up visits
8. Subjects ready to follow instructions during the study period.
1. Infection, allergy on the tested area.
2. Skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Cutaneous disease which may influence the study result.
5. Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
6. Subjects participating in any other cosmetic or therapeutic study.
7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the Erythema and Oedema (Draize scale) as per IS4011: 2018 by 24 hr patch under occlusionTimepoint: 0 hr, 24 hr, 48 hr and 7 days
- Secondary Outcome Measures
Name Time Method To assess the adverse eventsTimepoint: 0 hr, 24 hr, 48 hr and 7 days