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Skin Sensitisation (Modified Draize-95 Test)

NCT04402476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2020-06-17

No results posted yet for this study

Summary

Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves

Conditions

  • Skin Sensitisation

Interventions

DEVICE

Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.

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

Sponsors & Collaborators

  • PT. Medisafe Technologies

    lead INDUSTRY

Principal Investigators

  • Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED · Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-11-23
Primary Completion
2020-02-20
Completion
2020-04-06

Countries

  • Malaysia

Study Locations

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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 NCT04402476 on ClinicalTrials.gov