Clinical trial NCT03886987: Skin Sensitization Test (Modified Draize-95 Test)
Official title: Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Sensitisation
Keywords: Modified Draize-95 Test
Skin Sensitisation
Repeat Insult Patch Test
Lead sponsor: Central Medicare Sdn. Bhd.
Sponsor class: INDUSTRY
Collaborators: name: Consumer Product Testing Company, Inc.
First posted: 2019-03-22
Enrollment: 245
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: Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: 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

Negative control: Blank patch Dose: Not applicable
Primary purpose: SCREENING

Brief summary: Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.


Eligibility criteria: Inclusion Criteria:

* Subjects must be aged 18 to 65 years, inclusive;
* Subjects who have not participated in other voluntary testing for at least 30 days;
* Subjects must execute an Informed Consent Form that includes a HIPAA statement; and
* 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 trial.

Exclusion Criteria:

* Subjects who are in ill health, as determined by the PI;
* Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
* Subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial;
* Female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial;
* 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 confused 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 any indication of existing Type I allergy (immediate hypersensitivity) to natural rubber proteins;
* Subjects with a history of frequent irritation; or
* Subjects who have received endogenous or exogenous immunosuppressive treatment (or prolonged exposure to sun).

Primary outcomes:
measure: Irritation scored by Erythemal Scoring Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Company, Inc.
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Company, Inc.
name: Michael Caswell, Ph.D., CCRA, CCRC
role: PRINCIPAL_INVESTIGATOR
References: