Skin Sensitization Test (Modified Draize-95 Test)

YTY Industry (Manjung) Sdn Bhd

Status: Completed

Conditions: Skin Sensitisation

Treatments: Device: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE

Study type: Interventional

Funder types: Industry

Identifiers

NCT04274647

PR-MDT-02-17-19

Details and patient eligibility

About

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 at a level that may induce type IV allergy in the unsensitized general user population are present in a finished rubber containing medical device.

Full 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. To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff - Medical Glove Guidance Manual9. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Enrollment: 208 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

Device and Control

Experimental group

Description:

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose. 0.2ml

Treatment:

Device: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE