To evaluate the safety of products by skin sensitivity test on human subjects
- Registration Number
- CTRI/2017/05/008635
- Lead Sponsor
- ITC Life Sciences Technology Centre
- 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 & female subjects.
3) Subjects with Fitzpatrick skin type III to V.
4) Subjects willing to give a voluntary 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.
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.
6) Subjects participating in any other cosmetic or therapeutic trial.
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: Approximately 9 days for each subject
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil