CTRI/2021/03/032138
Not yet recruiting
未知
Evaluation of Dermatological Safety of Investigational Products by 24 hour Patch Test under Complete Occlusion on Healthy Human Subjects - Nil
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur India Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
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 normal, dry and oily
- •3\.Subjects with Fitzpatrick skin type III to V.
- •4\.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.
- •5\.Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •6\.Subjects willing to give a voluntary written informed consent.
- •7\.Subjects willing to maintain the patch test in position for 24 hours.
- •8\.Subject having not participated in a similar investigation in the past two weeks.
- •9\.Subjects willing to come for regular follow up visits.
- •10\.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\. Subjects with known hypersensitivity to any of the study products or constituents.
- •4\.Subjects with any significant skin pathology in the investigational area,
- •5\. Athletes and subjects with history of excessive sweating.
- •6\. Subjects with cutaneous disease which may influence the study result.
- •7\. Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
- •8\. Subjects on oral corticosteroid.
- •9\.Subjects participating in any other cosmetic or therapeutic trial.
- •10\.Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
Outcomes
Primary Outcomes
Not specified
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