CTRI/2016/12/007573
Completed
未知
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. - Nil
ITC Life Sciences and Technology Centre0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences and Technology Centre
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects in the age group 18 \- 55 years (both the ages inclusive).
- •2\) Healthy male and 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.
Exclusion Criteria
- •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 study.
- •7\)Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Outcomes
Primary Outcomes
Not specified
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