Skin Sensitization Test (Modified Draize-95 Test)

NCT03886987 | Completed FDA Device

• 1 other identifier: CTYP01-001
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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

Keywords

Modified Draize-95 Test; Skin Sensitisation; Repeat Insult Patch Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Device and Control

EXPERIMENTAL

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

Interventions

Blue Non Sterile Powder Free Nitrile Examination Gloves DEVICE

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

Device and Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Central Medicare Sdn. Bhd.: lead
• Consumer Product Testing Company, Inc.: collaborator

Study Sites (1)

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, 07004, United States

Location

Study Officials

• Michael Caswell, Ph.D., CCRA, CCRC

  Consumer Product Testing Company, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 22, 2019
• Study Start: April 2, 2018
• Primary Completion: June 8, 2018
• Study Completion: June 8, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)