Patch test on healthy subjects
- Registration Number
- CTRI/2022/05/042600
- Lead Sponsor
- ASCLEPIUS WELLNESS PVT 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. Willingness to avoid to contact water during course of study.
7. Subject having not participated in a similar investigation in the past one month.
8. Subjects willing to come for regular follow up visits.
9. Subjects ready to follow instructions during the study period.
10. Willingness to avoid intense UV exposure on test site ( sun or artificial UV), during the
course of the study.
1. Subjects having known hypersensitivity to the study product or its constituents.
2. Subjects having clinically significant active dermatitis or skin disease(s) anywhere in
the body.
3. Athletes and subjects with history of excessive sweating.
4. Cutaneous disease which may influence the study result.
5. Subjects on oral corticosteroid .
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.
8. Pregnant and lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the dermatological safety of investigational productTimepoint: Day 0 to Day 7
- Secondary Outcome Measures
Name Time Method To assess any adverse drug reactionTimepoint: Day 0 to Day 7