Skin Sensitisation (Modified Draize-95 Test)

PT. Medisafe Technologies208 enrolled

Overview

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

1. 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 Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH) 2. To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Skin Sensitisation

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days. * Age of the test subjects ranged from 18 to 65 years. * Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US Exclusion Criteria: * The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material. * The test subjects with any indication of existing Type I allergy to natural rubber proteins. * The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing. * Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure). * All subjects who are pregnant or become pregnant during the study. * All lactating women,

Locations (1)

Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

Kuala Lumpur, Cheras, Malaysia

Outcomes

Primary Outcomes

Induction Phase

Irritation scored by Erythemal Scoring Scale, Basic Score - 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.

Time frame: 24 days

Challenge Phase

Irritation scored by Erythemal Scoring Scale, Basic Score - 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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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