CORNERSTONE: China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Demographics [baseline]
Age, sex, ethnicity, body weight and height
- Age at Type 2 skin disease onset [baseline]
Age of study patients at time of Type 2 skin disease onset
- Type of current Type 2 skin disease therapy [Baseline]
Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)
- Presence of Type 2 skin disease and selected comorbid conditions [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
Secondary Outcome Measures
- Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies [Baseline to Month 120]
Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
- Eczema Area and Severity Index (EASI) [Baseline to Month 120]
EASI score as assessed by physician
- Body Surface Area (BSA) percentage affected by Type 2 skin disease [Baseline to Month 120]
BSA score as assessed by physician
- Patient Oriented Eczema Measure (POEM) questionnaire [Baseline to Month 120]
POEM score as reported by the participant's caregiver
- Dermatology Life Quality Index [Baseline to Month 120]
DLQI score as reported by the patients or caregivers
- Bullous Pemphigoid Disease Area Index(BPDAI) [Baseline to Month 120]
BPDAI score as assessed by physician
- Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [Baseline to Month 120]
ABSIS score as assessed by physician
- Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) [Baseline to Month 120]
CU-Q2oL score as assessed by patients or caregivers
- Urticaria Activity Score 7a （UAS7a） [Baseline to Month 120]
UAS7a score as assessed by physician
- Urticaria Control test (UCT) [Baseline to Month 120]
UCT score as assessed by patients or caregivers
Eligibility Criteria
Criteria
Inclusion Criteria:
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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);
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patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis).
Exclusion Criteria:
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patients who fail to provide informed consent form;
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patients who cannot complete the questionnaire independently or under the guidance of investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | China |
Sponsors and Collaborators
- Peking University First Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PKU202108