24 hour primary irritation patch test on healthy human volunteers
- Registration Number
- CTRI/2013/04/003524
- Lead Sponsor
- Kao Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Subjects age group 18 - 55 years
2.Healthy male & female volunteers
3.Subjects with 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 has not participated in a similar investigation in the past two weeks.
7.Subjects willing to come for regular follow up.
8.Subjects ready to follow instructions during the study period.
1.Infection, allergy on the tested area
2.History of skin allergy antecedents or atopic subjects
3.History of hyper sensitivity to any component of the tested products
4.Athletes and subjects with history of excessive sweating
5.Cutaneous disease which may influence the study result
6.Chronic illness which may influence the cutaneous state.
7.Subjects on oral corticosteroid
8.Subjects participating in any other cosmetic or therapeutic trial.
9.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 â?¢To evaluate the dermatological safety of the given investigational products on skin of healthy human volunteers by primary irritation patch test. <br/ ><br>Timepoint: 9 Days for each volunteer.
- Secondary Outcome Measures
Name Time Method â?¢To gather safety information prior to a pilot study and/or larger study, in order to improve the quality and efficiency of prospective studiesâ?? design. <br/ ><br>Timepoint: 9 Days for each volunteer.