Patch test study on healthy human volunteers under occlusion for 24hrs
- Registration Number
- CTRI/2018/02/012023
- Lead Sponsor
- ITC Life Sciences and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1)Subjects in the age group 18 - 55 years (both the ages inclusive).
2)Healthy male & 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 two weeks.
7)Subjects willing to come for regular follow up visits.
8)Subjects ready to follow instructions during the study period.
9)Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same
1)Infection, allergy on the tested area.
2)Skin allergy antecedents or atopic subjects.
3)Athletes and subjects with history of excessive sweating.
4)Cutaneous disease which may influence the study result.
5)Subjects on oral corticosteroid >10mg/day.
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 To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: time points 0hr, 24hr and 7days post patch removal
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil