Skin Sensitization Test (Modified Draize-95 Test)

Completed · Not applicable

Conditions studied: Skin Sensitisation

In brief

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.

Key facts

Study ID

NCT03886987

Run by

Central Medicare Sdn. Bhd.

People needed

245

Starts

2018-04-02

Expected to finish

2018-06-08

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Consumer Product Testing Company, Inc. — Fairfield, New Jersey, United States

Full record on ClinicalTrials.gov

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