Skin Sensitization Test (Modified Draize-95 Test)

Central Medicare Sdn. Bhd.

Status: Completed

Conditions: Skin Sensitisation

Treatments: Device: Blue Non Sterile Powder Free Nitrile Examination Gloves

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03886987

CTYP01-001

Details and patient eligibility

About

Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.

Enrollment: 245 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be aged 18 to 65 years, inclusive;
• Subjects who have not participated in other voluntary testing for at least 30 days;
• Subjects must execute an Informed Consent Form that includes a HIPAA statement; and
• 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 trial.

Exclusion criteria

• Subjects who are in ill health, as determined by the PI;
• Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
• Subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial;
• Female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial;
• 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 confused 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 any indication of existing Type I allergy (immediate hypersensitivity) to natural rubber proteins;
• Subjects with a history of frequent irritation; or
• Subjects who have received endogenous or exogenous immunosuppressive treatment (or prolonged exposure to sun).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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245 participants in 1 patient group

Device and Control

Experimental group

Description:

Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: 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: 0.2 ml Negative control: Blank patch Dose: Not applicable

Treatment:

Device: Blue Non Sterile Powder Free Nitrile Examination Gloves