To test the skin irritation reactions of Silk n Stay REFRESHING BAR by 24hrs patch test
- Registration Number
- CTRI/2022/07/044088
- Lead Sponsor
- SBL Private Limited
- 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 month.
1. Infection, allergy on the tested area.
2. Skin allergy, antecedents, or atopic subjects.
3. Athletes and subjects with a 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 Skin reactions Erythema (including dryness, <br/ ><br>scaliness and wrinkles) on a 0-4 point scale and <br/ ><br>Oedema on another 0-4 points scales per Draize <br/ ><br>scale.Timepoint: Day 1, Day 2 and Day 7
- Secondary Outcome Measures
Name Time Method To assess the Adverse Events if any.Timepoint: 0 to 7 days