CTRI/2024/02/062777
Completed
未知
Evaluation of dermatological safety of investigational products by 24hrs patchtest under complete occlusion on healthy human subjects - NI
Transformative Learning Solutions Pvt Ltd0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Transformative Learning Solutions Pvt Ltd
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects in age group 18 \- 65 years (both the ages inclusive).
- •2\.Healthy male \& female subjects with skin types as defined in the population details under appendix 1\.
- •3\.Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •4\.Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •5\.Subjects willing to give a voluntary written informed consent.
- •6\.Subjects willing to maintain the patch test in position for 24 hours.
- •7\.Subject having not participated in a similar investigation in the past two weeks.
- •8\.Subjects willing to come for regular follow up visits.
- •9\.Subjects ready to follow instructions during the study period.
Exclusion Criteria
- •1\.Subjects with infection, allergy on the tested area.
- •2\.Subjects with skin allergy, antecedents or atopic subjects.
- •3\.Athletes and subjects with history of excessive sweating.
- •4\.Subjects with cutaneous disease which may influence the study result.
- •5\.Subjects on oral corticosteroid.
- •6\.Subjects participating in any other cosmetic or therapeutic trial.
- •7\.Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •8\.Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •9\.More than one subject selected/participating from one family/household.
- •10\.Subjects working with MSCR
Outcomes
Primary Outcomes
Not specified
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