Repeat closed patch test study to evaluate the irritation test materials by repeated insult patch test method by pasting patch on the upper back of healthy human subjects.
- Registration Number
- CTRI/2012/12/003233
- Lead Sponsor
- KAYA Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Subjects age group 18 - 55 years
Healthy male & female volunteers
Subjects with skin type III to V.
Subjects willing to give a written informed consent.
Subjects willing to maintain the patch test in position as directed.
Subject has not participated in a similar investigation in the past four weeks.
Subjects willing to come for regular follow up and patch application visits.
Subjects ready to follow instructions during the study period
Skin allergy antecedents or atopic subjects
Hypersensitivity to any component of the tested products
Athletes and subjects with history of excessive sweating
Cutaneous disease which may influence the study result
Chronic illness which may influence the cutaneous state.
Subjects on oral corticosteroid with dose >10mg/day
Subjects participating in any other cosmetic or therapeutic trial.
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 determine the irritation and/or sensitization potential of a test material(s) under occlusionTimepoint: To determine the irritation and/or sensitization potential of a test material(s) under occlusion
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI