Skin Sensitization Test (Modified Draize-95 Test)

Not Applicable

Completed

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

• Registration Number: NCT04274647
• Lead Sponsor: YTY Industry (Manjung) Sdn Bhd

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

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. 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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-09-10
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-12
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device and Control	NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE	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

Primary Outcome Measures

Name	Time	Method
Irritation scored by Erythemal Scoring Scale	8 weeks	0 - No visible reaction

Trial Locations

Locations (1)

Samy; 🇲🇾 Sitiawan, Perak, Malaysia