Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2019-11-23
2020-04-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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,
18 Years
65 Years
ALL
Yes
Sponsors
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PT. Medisafe Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED
Role: STUDY_DIRECTOR
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
Locations
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Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
Kuala Lumpur, Cheras, Malaysia
Countries
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References
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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.
Related Links
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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.
Other Identifiers
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HMR-MDT-02-19-19-PT.MT
Identifier Type: -
Identifier Source: org_study_id
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