Skin Sensitisation (Modified Draize-95 Test)

Skin Sensitisation Clinical Trial

— MDT-95  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402476
• Other study ID #: HMR-MDT-02-19-19-PT.MT
• Status: Completed
• Phase: N/A
• Start date: November 23, 2019
• Est. completion date: April 6, 2020

Study information

• Verified date: June 2020
• Source: PT. Medisafe Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 6, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Skin Sensitisation

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.	Kuala Lumpur	Cheras

Sponsors (1)

Lead Sponsor	Collaborator
PT. Medisafe Technologies

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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