Clinical trial NCT04274647: Skin Sensitization Test (Modified Draize-95 Test)
Official title: Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Sensitisation
Lead sponsor: YTY Industry (Manjung) Sdn Bhd
Sponsor class: INDUSTRY
First posted: 2020-02-18
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: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Primary purpose: TREATMENT

Brief summary: Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. 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 rubber containing medical device.

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 rubber containing medical device.
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 Manual9. 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:

* Subjects must be aged 18 and 65 years, inclusive;
* Subjects who have not participated in other voluntary testing for at least 30 days;
* Subjects must be capable of understanding and following directions.
* Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the tiral.

Exclusion Criteria:

* Subjects who are in ill health;
* Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral;
* Subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral;
* Femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral;
* Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
* Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
* Subjects with any visible skin disease that might be confuesd with skin reactions caused by the test material;
* Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
* Subjects with a history of frequent irritation; or
* Subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).

Primary outcomes:
measure: Irritation scored by Erythemal Scoring Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sitiawan
country: Malaysia
facility: Samy
state: Perak
Study officials:
References: