NCT04455906招募中不适用
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- atopic dermatitis severity
研究概览
简要总结
This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.
详细描述
For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥6 to 65 yrs of age
- •Meet AD Standard Diagnostic Criteria
排除标准
- •Enrollment in another clinical trial
- •Hypersensitivity to an agent used for the skin decolonization protocol
- •Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)
- •Phototherapy for AD within 4 weeks
- •Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
- •Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days
- •Bleach baths within 7 days of the first Visit
- •Use of oral or topical antibiotics within 21 days of the beginning of the study
- •Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
- •History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
- •Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
- •Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
- •Febrile illness at time of visits
- •Suspected immune deficiency or family history of primary immunodeficiency
结局指标
主要结局
atopic dermatitis severity
时间窗: baseline, only 1 time point
validated assessment EASI score
次要结局
未报告次要终点
研究者
Wanda Phipatanakul
Professor of Pediatrics, Director Asthma Research Center
Harvard Medical School (HMS and HSDM)
研究点 (2)
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