Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Skin reaction to the patch test after 72-96 hours and after 7 days
研究概览
简要总结
The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
详细描述
Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.
The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive bacitracin patch test within the latest 5 years.
- •Age greater than or equal to 18 years.
- •Signed informed consent.
排除标准
- •Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
- •Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
- •Treatment with ultraviolet (UV)-light during the latest 3 weeks.
- •Widespread active dermatitis or dermatitis on test area.
- •Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
- •Subjects not able to cooperate.
结局指标
主要结局
Skin reaction to the patch test after 72-96 hours and after 7 days
次要结局
- Evaluation of safety including late and persistent responses
- Evaluation day 3/4, day 7 and day 21