MedTrace Logo

Skin Sensitization Test (Modified Draize-95 Test)

NCT03886987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2019-03-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Consumer Product Testing Company, Inc.

    collaborator UNKNOWN

  • Central Medicare Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Michael Caswell, Ph.D., CCRA, CCRC · Consumer Product Testing Company, Inc.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2018-06-08
Completion
2018-06-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886987 on ClinicalTrials.gov