China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project

Study Overview
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Brief Summary
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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.

Official Title
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China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study

Conditions
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Atopic Dermatitis Eczema, Prurigo Nodularis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: patients who fail to provide informed consent form; patients who cannot complete the questionnaire independently or under the guidance of investigators
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Age, sex, ethnicity, body weight and height | baseline | 
| Age at Type 2 skin disease onset | Age of study patients at time of Type 2 skin disease onset | baseline | 
| Type of current Type 2 skin disease therapy | Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other) | Baseline | 
| Presence of Type 2 skin disease and selected comorbid conditions | Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study | Baseline to Month 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies | Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies | Baseline to Month 120 | 
| Eczema Area and Severity Index (EASI) | EASI score as assessed by physician | Baseline to Month 120 | 
| Body Surface Area (BSA) percentage affected by Type 2 skin disease | BSA score as assessed by physician | Baseline to Month 120 | 
| Patient Oriented Eczema Measure (POEM) questionnaire | POEM score as reported by the participant's caregiver | Baseline to Month 120 | 
| Dermatology Life Quality Index | DLQI score as reported by the patients or caregivers | Baseline to Month 120 | 
| Bullous Pemphigoid Disease Area Index(BPDAI) | BPDAI score as assessed by physician | Baseline to Month 120 | 
| Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) | ABSIS score as assessed by physician | Baseline to Month 120 | 
| Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) | CU-Q2oL score as assessed by patients or caregivers | Baseline to Month 120 | 
| Urticaria Activity Score 7a （UAS7a） | UAS7a score as assessed by physician | Baseline to Month 120 | 
| Urticaria Control test (UCT) | UCT score as assessed by patients or caregivers | Baseline to Month 120 |