DRKS00012455已完成不适用
A mechanistic study to determine the relevance of Benralizumab targets (eosinophil-numbers and IL5-receptor) in patients with skin disorders. - ROBERTIS (Relevance of Benralizumab targets in skin disorders)
Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie0 个研究点目标入组 74 人开始时间: 2017年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Diagnosis: Patients with any of the following skin diseases will be included in the study, either prospectively or retrospectively:
- •Chronic spontaneous urticaria
- •Atopic dermatitis
- •Bullous pemphigoid
- •Mycosis fungoides
- •Granuloma anulare
- •Dermatitis herpetiformis
- •Healthy controls
- •Key inclusion criteria:
- •Adults (18 years or older)
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •Willing, committed and able to complete all study-related procedures
- •Patients may have additional concomitant disease, but only one dominant skin disease.
- •No participation in other clinical trials 4 weeks before in this study
排除标准
- •Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to study entry whichever is longer
- •Prior or concurrent treatment with oral or systemic Corticosteroids within last 4 weeks,
- •Prior or concurrent treatment with topical Corticosteroids within last 2 weeks at the sites of skin biopsy.
- •Concurrent/ongoing treatment with Omomalizumab within 3 months prior to study entry
- •Prior or concurrent treatment with Mepolizumab or Resilizumab.
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- •Lactating females or pregnant females
- •Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial
- •Subjects for whom there is concern about compliance with the protocol procedures
- •Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
- •Subjects who are detained officially or legally to an official institute
- •Intake of leukotriene antagonists within 7 days prior to study entry
- •History of hypersensitivity/allergy to local anesthetics
- •History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject’s ability to comply with study procedures.
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