Skin Sensitization Test (Modified Draize-95 Test) (Draize-95)

Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Perak
    • Sitiawan, Perak, Malaysia, 32020
      • Samy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device and Control; 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation scored by Erythemal Scoring Scale	0 - No visible reaction	8 weeks

Collaborators and Investigators

• Sponsor: YTY Industry (Manjung) Sdn Bhd

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PR-MDT-02-17-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No