Skin Sensitisation Clinical Trial
— Draize-95Official title:
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
Verified date | July 2019 |
Source | YTY Industry (Manjung) Sdn Bhd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 208 |
Est. completion date | February 12, 2020 |
Est. primary completion date | February 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Malaysia | Samy | Sitiawan | Perak |
Lead Sponsor | Collaborator |
---|---|
YTY Industry (Manjung) Sdn Bhd |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Irritation scored by Erythemal Scoring Scale | 0 - No visible reaction | 8 weeks |
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