Status:
COMPLETED
Skin Sensitization Test (Modified Draize-95 Test)
Lead Sponsor:
YTY Industry (Manjung) Sdn Bhd
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 Blue Non Sterile Powder Free Nitrile Examination Gloves. To evaluate whether residual chemical additives ...
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 rubber containing medical device. 2....
Eligibility Criteria
Inclusion
- Subjects must be aged 18 and 65 years, inclusive;
- Subjects who have not participated in other voluntary testing for at least 30 days;
- Subjects must be capable of understanding and following directions.
- Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the tiral.
Exclusion
- Subjects who are in ill health;
- Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral;
- Subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral;
- Femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral;
- Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
- Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
- Subjects with any visible skin disease that might be confuesd with skin reactions caused by the test material;
- Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
- Subjects with a history of frequent irritation; or
- Subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04274647
Start Date
September 10 2019
End Date
February 12 2020
Last Update
February 18 2020
Active Locations (1)
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1
Samy
Sitiawan, Perak, Malaysia, 32020