CTRI/2021/04/032587
Completed
未知
Evaluation of Dermatological safety of Test products by primary irritation patch test on healthy human volunteers of varied skin types
Freedom Fragrances0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Freedom Fragrances
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male and female subjects in the age group of 18\-45 years (both age inclusive)
- •2\. Subjects with Fitzpatrick skin type III to V
- •3\. Subjects willing to give a voluntary written informed consent
- •4\. Subjects willing to maintain the test patches in designated positions for 24 Hours
- •5\. Subjects having not participated in a similar investigation in the past two weeks
- •6\. Subjects willing to come for regular follow up visits
- •7\. Subjects ready to follow instructions during the study period
- •8\. Subjects without any open wounds, cuts, abrasions, irritation symptoms
Exclusion Criteria
- •1\. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application
- •2\. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results
- •3\. Subject is Pregnant or Lactating
- •4\. Athletes and subjects with a history of excessive sweating
- •5\. Subjects on an oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results
- •6\. Subjects participating in any other cosmetic or therapeutic trial
- •7\. Subjects with 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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