China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Age at Type 2 skin disease onset
研究概览
简要总结
In order to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for type 2 inflammatory skin diseases to systematically and effectively understand the current treatment status of patients with type 2 inflammatory skin diseases, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases and help patients with type 2 inflammatory skin diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the medical units that has passed the data review of the National Clinical Center for Skin and Immune Diseases (see the study sites for data collection for details);
- •patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis).
排除标准
- •patients who fail to provide informed consent form;
- •patients who cannot complete the questionnaire independently or under the guidance of investigators
结局指标
主要结局
Age at Type 2 skin disease onset
时间窗: baseline
Age of study patients at time of Type 2 skin disease onset
Presence of Type 2 skin disease and selected comorbid conditions
时间窗: Baseline to Month 120
Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study
Demographics
时间窗: baseline
Age, sex, ethnicity, body weight and height
Type of current Type 2 skin disease therapy
时间窗: Baseline
Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)
次要结局
- Patient Oriented Eczema Measure (POEM) questionnaire(Baseline to Month 120)
- Dermatology Life Quality Index(Baseline to Month 120)
- Eczema Area and Severity Index (EASI)(Baseline to Month 120)
- Body Surface Area (BSA) percentage affected by Type 2 skin disease(Baseline to Month 120)
- Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies(Baseline to Month 120)
- Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)(Baseline to Month 120)
- Urticaria Activity Score 7a （UAS7a）(Baseline to Month 120)
- Urticaria Control test (UCT)(Baseline to Month 120)
- Bullous Pemphigoid Disease Area Index(BPDAI)(Baseline to Month 120)
- Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)(Baseline to Month 120)