24 hours patch test to verify the Primary irritation of a research product
- Registration Number
- CTRI/2014/02/004427
- Lead Sponsor
- Stempeutics Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Healthy male and female subjects in the ration of 1:1.
Subjects with skin phototype III to V and Subjects willing to keep the patch in position for 24 hours.
Subjects willing to come for follow up visit at specified interval for 9 days.
Subjects ready to follow instructions during the study period.
Subjects with healthy skin on the studied anatomic unit (free of eczema, wounds and inflammatory scars).
Subjects representing varied skin types (representation of all 4 skin types â?? oily, normal, dry and combination).
Subjects having infection, allergy, bruises or scars on the area to be tested.
Subjects having known hypersensitivity to any component of the tested products.
Subjects having sensitivity to penicillin, based on history or as confirmed by a sensitivity test on forearm.
Athletes and subjects with history of excessive sweating.
Subjects with cutaneous disease that may influence the study result as per investigatorâ??s judgment.
Subjects having chronic illness that may influence the cutaneous state (for example: SLE) as per investigatorâ??s judgment.
Subjects on oral corticosteroid therapy.
Any history of underlying uncontrolled medical illness (including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness) which in the investigatorâ??s opinion will have safety concerns for the subject.
For females: Being pregnant or breastfeeding or having stopped breastfeeding within the last three months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method verification of safety of Investigation product by evaluating the irritation potentialTimepoint: 24hrs 48hrs and 7 days after patch application
- Secondary Outcome Measures
Name Time Method DrynessTimepoint: 24hrs 48hrs and 7 days after patch application