NCT01842711已完成不适用
Exclusive Cumulative Irritation Patch Test (21 Day) With Challenge Patch Application
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Primary or Cumulative Irritation Potential of the skin
研究概览
简要总结
A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical agent or agents have the potential to cause contact irritation or contact allergy in the skin. Allergy is only elicited in immunologically competent individuals who have become sensitized through exposure to the chemical agent at a sufficient concentration and for a sufficient duration of time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must not have any visible skin disease that might be confused with a skin reaction to the test trial;
- •Subjects must not be participating in another clinical trial at this facility or any other facility;
- •Subjects must be willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
- •Subjects must understand and execute and Informed Consent Form;
- •Subjects must be capable of understanding and following directions;
- •Subjects must be considered reliable;
- •Subjects must be aged 16 to 79 years, inclusive;
- •Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form.
排除标准
- •Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial;
- •Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial;
- •Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products;
- •Subjects judged by the PI to be inappropriate for the trial.
结局指标
主要结局
Primary or Cumulative Irritation Potential of the skin
时间窗: 21 days
This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation.
次要结局
- Allergic Contact Sensitization Potential(21 days)
研究者
研究点 (1)
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