Skin Sensitization Test (Modified Draize-95 Test)

Skin Sensitisation Clinical Trial

— Draize-95  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274647
• Other study ID #: PR-MDT-02-17-19
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: July 2019
• Source: YTY Industry (Manjung) Sdn Bhd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: February 12, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Skin Sensitisation

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Samy	Sitiawan	Perak

Sponsors (1)

Lead Sponsor	Collaborator
YTY Industry (Manjung) Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritation scored by Erythemal Scoring Scale	0 - No visible reaction	8 weeks