NCT04274647

Completed

Skin Sensitization Test (Modified Draize-95 Test)

YTY Industry (Manjung) Sdn Bhd Source

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Other study identifiers

Sponsor study identifier

PR-MDT-02-17-19

Study Type

interventional

Actual enrollment (reported)

208

Locations

1 country

Sites

1

Timeline

Study Start

September 10, 2019

Actual (reported)

Primary Completion

February 4, 2020

Actual (reported)

Study Completion

February 12, 2020

Actual (reported)

Brief Summary

Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. To evaluate whether residual chemical additives at a level that may induce type IV allergy in the unsensitized general user population are present in a finished rubber containing medical device.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 208 participants
Study completion date: February 12, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 10, 2019
Actual (reported)
Primary Completion
February 4, 2020
Actual (reported)
Study Completion
February 12, 2020
Actual (reported)
First Submitted
February 17, 2020
Actual (reported)
First Posted
February 18, 2020
Actual (reported)

Last Updated: February 18, 2020
Status Verified: July 2019
Last Update Submitted: February 17, 2020

Conditions

Skin Sensitisation

Outcome Measures

Primary Outcomes (1)

Irritation scored by Erythemal Scoring Scale
0 - No visible reaction
8 weeks

Study Arms (1)

Device and Control

EXPERIMENTAL

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE 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. 0.2ml

Device: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE

Interventions

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUEDevice

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

Device and Control

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must be aged 18 and 65 years, inclusive;
Subjects who have not participated in other voluntary testing for at least 30 days;

Sponsors & Collaborators

YTY Industry (Manjung) Sdn Bhd
Industrylead

Study Sites (1)

Samy

Sitiawan, Perak, 32020, Malaysia

Enrollment

208 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 18, 2020

Study Start

September 10, 2019

Actual (reported)

NCT05559697

Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days

Not ApplicableCompleted

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 tiral.

You may not qualify if:

Subjects who are in ill health;
Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral;
Subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral;
Femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral;
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 confuesd 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 a history of frequent irritation; or
Subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).

Contact the study team to confirm eligibility.

Primary Completion

February 4, 2020

Actual (reported)

Study Completion

February 12, 2020

Actual (reported)

Last Updated

February 18, 2020

Record last verified: 2019-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04274647
Data provider: ClinicalTrials.gov
Source updated: 2020-02-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:48 UTC

Locations

MY(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Device and Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations