CTRI/2020/05/025311
Not yet recruiting
未知
To Evaluate Dermatological Safety of InvestigationalProducts by 24 Hours Patch Test under CompleteOcclusion on Adult Healthy Human Subjects WithNormal Skin Type - SAFE/DAPT/2020-01
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\.Healthy male and female subjects (1:1 ratio) in the age group of 18\-65 years (both age
- •inclusive).
- •2\. Subjects with normal skin
- •3\. Subjects with Fitzpatrick skin type III to V.
- •4\. Female subjects with child bearing potential willing to undergo Urine Pregnancy Test.
- •5\. Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any
- •other skin condition which may interfere in the study results.
- •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.
Exclusion Criteria
- •1\. Infection, allergy on the tested area.
- •2\. 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\. 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
- •8\. Subjects on oral corticosteroid.
- •9\. Subjects participating in any other cosmetic or therapeutic study.
Outcomes
Primary Outcomes
Not specified
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