Status:
COMPLETED
Skin Sensitisation (Modified Draize-95 Test)
Lead Sponsor:
PT. Medisafe Technologies
Conditions:
Skin Sensitisation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at ...
Detailed Description
1. To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished Polychloroprene Rubber Containing Me...
Eligibility Criteria
Inclusion
- The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
- Age of the test subjects ranged from 18 to 65 years.
- Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US
Exclusion
- The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
- The test subjects with any indication of existing Type I allergy to natural rubber proteins.
- The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
- Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
- All subjects who are pregnant or become pregnant during the study.
- All lactating women,
Key Trial Info
Start Date :
November 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2020
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04402476
Start Date
November 23 2019
End Date
April 6 2020
Last Update
June 17 2020
Active Locations (1)
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1
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
Kuala Lumpur, Cheras, Malaysia, 56000