EUCTR2007-007130-19-DK进行中（未招募）不适用
Clinical Evaluation of TRUE TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study - Dose Response Trial
Allerderm0 个研究点目标入组 40 人开始时间: 2008年1月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •*Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol ORCurrent or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to disperse blue 106 or disperse blue 106/124 allergen mix.
- •*All subjects must be adults (18 years of age or older) and otherwise in good health.
- •*Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
- •*Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*Subjects unable to meet inclusion requirements.·Women who are breastfeeding or pregnant.
- •*Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
- •*Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
- •*Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
- •*Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- •*Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- •*Subject participation in clinical trials of investigational drugs, treatments or devices other than TRUE TEST during this study or 3 weeks prior to inclusion in this study.
研究者
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