Clinical trial NCT04402476: Skin Sensitisation (Modified Draize-95 Test)
Official title: Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Sensitisation
Lead sponsor: PT. Medisafe Technologies
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Induction Phase
timeFrame: 24 days
measure: Challenge Phase
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
state: Cheras
Study officials:
affiliation: Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
name: Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1007/BF00381346.
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. doi: 10.1034/j.1600-0536.2002.460205.x.