Skin Sensitization Test (Modified Draize-95 Test)

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Sensitisation
• Intervention / Treatment: Device: Blue Non Sterile Powder Free Nitrile Examination Gloves

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fairfield, New Jersey, United States, 07004
      • Consumer Product Testing Company, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• 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; 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation scored by Erythemal Scoring Scale	Basic Score and Description: 0 - No visible reaction. 0.5 - Doubtful or negligible erythema reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site. If a subject develops a positive reaction (a score value of 1.5) to the test material or shows signs of irritation after patch applications, further patching on those individuals are stopped. In order to qualify for the claim of a reduced sensitization potential, all 200 individuals completing the study should exhibit a score value of no more than 1.5 based on the scoring criteria.	8 weeks

Collaborators and Investigators

• Sponsor: Central Medicare Sdn. Bhd.
• Collaborators: Consumer Product Testing Company, Inc.
• Investigators: Principal Investigator: Michael Caswell, Ph.D., CCRA, CCRC, Consumer Product Testing Company, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 8, 2018

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Modified Draize-95 Test; Skin Sensitisation; Repeat Insult Patch Test
• Other Study ID Numbers: CTYP01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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