Skin Sensitisation (Modified Draize-95 Test) (MDT-95)

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

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 Overview

• Status: Completed
• Conditions: Skin Sensitisation
• Intervention / Treatment: Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.

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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Cheras
    • Kuala Lumpur, Cheras, Malaysia, 56000
      • Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device and Control; 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.; Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PT. Medisafe Technologies
• Investigators: Study Director: Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED, Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

Publications and helpful links

General Publications

• Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. doi: 10.1034/j.1600-0536.2001.450605.x.
• Kompaore F, Tsuruta H. In vivo differences between Asian, black and white in the stratum corneum barrier function. Int Arch Occup Environ Health. 1993;65(1 Suppl):S223-5. doi: 10.1007/BF00381346.
• Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis. 2002 Feb;46(2):86-93. doi: 10.1034/j.1600-0536.2002.460205.x.

Helpful Links

• Medical Glove Guidance Manual
• Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2019
• Primary Completion (ACTUAL): February 20, 2020
• Study Completion (ACTUAL): April 6, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HMR-MDT-02-19-19-PT.MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No