Skin sensitivity test to evaluate sensitization of test product by standard HRIPT method
- Registration Number
- CTRI/2022/03/040710
- Lead Sponsor
- SBL Private ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Subjects in the 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 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 month.
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 1. Mean Cumulative irritancy Index using Draize scale for scoring the treatment sites (Erythema and Oedema) during Induction phase <br/ ><br>2. Skin sensitisation using ICDRG scale for scoring the treatment sites as <br/ ><br>per IS 4011:2018 during challenge phaseTimepoint: o to 37 Days
- Secondary Outcome Measures
Name Time Method To assess the adverse EventsTimepoint: 0 to 37 days