China Atopic Dermatitis Registry Study
China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
研究概览
详细说明
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Jianzhong Zhang
- 电话号码:010-88325472
- 邮箱:rmzjz@126.com
研究联系人备份
- 姓名:Ping Liu
- 电话号码:010-88325472
- 邮箱:llppliuping@126.com
学习地点
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Beijing
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Beijing、Beijing、中国、100044
- 招聘中
- Peking University People's Hospital
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接触:
- Ping Liu
- 电话号码:010 88325472
- 邮箱:llppliuping@126.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Exclusion Criteria:
- No.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy
|
无干预
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
大体时间:At Month 12
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Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
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At Month 12
|
|
Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
大体时间:At Month 12
|
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
|
At Month 12
|
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Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
大体时间:At Month 12
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Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
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At Month 12
|
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Patient-reported disease control after Atopic Dermatitis therapies in real life
大体时间:At Month 12
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Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
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At Month 12
|
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Patient-reported quality of life after Atopic Dermatitis therapies in real life
大体时间:At Month 12
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Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
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At Month 12
|
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The Atopic Dermatitis related economic burden
大体时间:At Month 12
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Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
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At Month 12
|
合作者和调查者
调查人员
- 首席研究员:Jianzhong Zhang、Peking University People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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