Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Sensitization Test (Modified Draize-95 Test)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886987
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Consumer Product Testing Company, Inc.
Information provided by (Responsible Party):
Central Medicare Sdn. Bhd.

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.

Condition or disease Intervention/treatment Phase
Skin Sensitisation Device: Blue Non Sterile Powder Free Nitrile Examination Gloves Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Intervention Model: Single Group Assignment
Intervention Model 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

Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

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.




Primary Outcome Measures :
  1. Irritation scored by Erythemal Scoring Scale [ Time Frame: 8 weeks ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886987


Locations
Layout table for location information
United States, New Jersey
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, United States, 07004
Sponsors and Collaborators
Central Medicare Sdn. Bhd.
Consumer Product Testing Company, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Michael Caswell, Ph.D., CCRA, CCRC Consumer Product Testing Company, Inc.

Layout table for additonal information
Responsible Party: Central Medicare Sdn. Bhd.
ClinicalTrials.gov Identifier: NCT03886987     History of Changes
Other Study ID Numbers: CTYP01-001
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Central Medicare Sdn. Bhd.:
Modified Draize-95 Test
Skin Sensitisation
Repeat Insult Patch Test