CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04402476
NCT04402476N/ACompleted
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Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim

PT. Medisafe Technologies·interventional·Posted May 26, 2020·Updated Jun 17, 2020

In Brief

A clinical study evaluating Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. for Skin Sensitisation. Completed, enrolled 208 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Sensitisation
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 26, 2020
Enrollment StartNov 23, 2019
Primary CompletionFeb 20, 2020
Study CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago

Interventions

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

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