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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04402476
Other study ID # HMR-MDT-02-19-19-PT.MT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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
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