Skin Sensitization Test (Modified Draize-95 Test)

NCT ID: NCT03886987

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2018-06-08

Brief Summary

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.

Conditions

Skin Sensitisation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Device and Control

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

Group Type: EXPERIMENTAL

Blue Non Sterile Powder Free Nitrile Examination Gloves

Intervention Type: DEVICE

Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.

Interventions

Blue Non Sterile Powder Free Nitrile Examination Gloves

Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consumer Product Testing Company, Inc.

UNKNOWN

Sponsor Role: collaborator

Central Medicare Sdn. Bhd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Caswell, Ph.D., CCRA, CCRC

Role: PRINCIPAL_INVESTIGATOR

Consumer Product Testing Company, Inc.

Locations

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, United States

Countries

United States

Other Identifiers

CTYP01-001

Identifier Type: -

Identifier Source: org_study_id