Skin Sensitisation (Modified Draize-95 Test)
- Conditions
- Skin Sensitisation
- Interventions
- Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.
- Registration Number
- NCT04402476
- Lead Sponsor
- PT. Medisafe Technologies
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device and Control Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. 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
- Primary Outcome Measures
Name Time Method Induction Phase 24 days 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.Challenge Phase 48 hours 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
🇲🇾Kuala Lumpur, Cheras, Malaysia