CTRI/2022/01/039814
Completed
未知
Evaluation of dermatological safety of test products by primary irritation patch test on healthy human volunteers of varied skin types
Asclepius Wellness Pvt Ltd0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Asclepius Wellness Pvt Ltd
- 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\-55 years (both age inclusive)
- •2\. Subject is having valid proof of identity and age
- •3\. Subjects with skin phototype III to V
- •4\.Subject is having apparently healthy skin on test area
- •5\.Subject representing normal, oily, dry and combination skin type in nearly equal ratio
- •6\. Subject willing to give a voluntary written informed consent
- •7\. Subject willing to maintain the test patches in designated positions for 24 Hours
- •8\. Subject willing to come for regular follow up visits
- •9\. Subject ready to follow instructions during the study period
- •10\. Subject without any open wounds, cuts, abrasions, irritation symptoms
Exclusion Criteria
- •1\. Subjects with Known hypersensitivity to any of the study products or constituents
- •2\. Subjects having any significant pathology in the test area
- •3\. Subjects with any kind of skin allergy, antecedents or cutaneous disease which may
- •influence the study results
- •4\. Subjects having topical or systemic treatment in last month prior to participation in the
- •study and during the study that could interfere with the study treatments/ assessments
- •5\. Athletes and subjects with history of excessive sweating
- •6\. Subject is Pregnant or Lactating
- •7\. Subject with any significant medical condition that would interfere with the participation in the trial
- •8\. Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation
Outcomes
Primary Outcomes
Not specified
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