CTRI/2018/02/012205
Completed
未知
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type. - NI
ITC Life Sciences Technology Centre0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences 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 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 (As per protocol)and by dermatological evaluation for the confirmation of the same.
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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