NCT04274647已完成不适用
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Irritation scored by Erythemal Scoring Scale
研究概览
简要总结
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.
详细描述
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Irritation scored by Erythemal Scoring Scale
时间窗: 8 weeks
0 - No visible reaction
次要结局
未报告次要终点
研究者
研究点 (2)
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