Skin Sensitisation (Modified Draize-95 Test)

Study Overview
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Brief Summary
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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

Detailed Description
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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) 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.

Official Title
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Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim

Conditions
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Skin Sensitisation

Intervention / Treatment
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* Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device and Control<br>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. Positive Control: 0.4% Sodium Lauryl Sulfate (SLS) Dose. 0.2 ml | Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.<br>* Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 48 hours |