China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
研究概览
简要总结
This regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies.
详细描述
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
时间窗: At Month 12
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
时间窗: At Month 12
Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
时间窗: At Month 12
Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
Patient-reported quality of life after Atopic Dermatitis therapies in real life
时间窗: At Month 12
Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
Patient-reported disease control after Atopic Dermatitis therapies in real life
时间窗: At Month 12
Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
The Atopic Dermatitis related economic burden
时间窗: At Month 12
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.
次要结局
未报告次要终点
研究者
Zhang jianzhong
Professor and Chairman, Department of Dermatology
Peking University People's Hospital