Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for "TRUE Test® Panel 3" - a Phase II, Dose-Response Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
研究概览
简要总结
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
详细描述
The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, 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 TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.
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 MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
- •Age more 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 UV-light during the latest 3 weeks.
- •Widespread active dermatitis or dermatitis on test area.
- •Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
- •Subjects not able to cooperate.
- •Participation in other clinical studies during the study period and 3 weeks prior to study start.
结局指标
主要结局
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
次要结局
- Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])