Skin Sensitisation (Modified Draize-95 Test)

NCT04402476 | Completed

• 1 other identifier: HMR-MDT-02-19-19-PT.MT
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Sensitisation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device and Control

EXPERIMENTAL

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.

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.

Device and Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 104 female (50%) and 104 male (50%)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• PT. Medisafe Technologies: lead

Study Sites (1)

Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

Kuala Lumpur, Cheras, 56000, Malaysia

Location

Related 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. doi: 10.1034/j.1600-0536.2001.450605.x.

  PMID: 11846750 RESULT

• 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.

  PMID: 8406931 RESULT

• 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.

  PMID: 11918601 RESULT

Related 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 Officials

• Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED

  Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: November 23, 2019
• Primary Completion: February 20, 2020
• Study Completion: April 6, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)