Clinical trial NCT05316805: China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project
Official title: China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis Eczema
Prurigo Nodularis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit)

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.


Eligibility criteria: Inclusion Criteria:

1. 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);
2. patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis).

Exclusion Criteria:

1. patients who fail to provide informed consent form;
2. patients who cannot complete the questionnaire independently or under the guidance of investigators

Primary outcomes:
measure: Demographics
timeFrame: baseline
measure: Age at Type 2 skin disease onset
timeFrame: baseline
measure: Type of current Type 2 skin disease therapy
timeFrame: Baseline
measure: Presence of Type 2 skin disease and selected comorbid conditions
timeFrame: Baseline to Month 120
Secondary outcomes:
measure: Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
timeFrame: Baseline to Month 120
measure: Eczema Area and Severity Index (EASI)
timeFrame: Baseline to Month 120
measure: Body Surface Area (BSA) percentage affected by Type 2 skin disease
timeFrame: Baseline to Month 120
measure: Patient Oriented Eczema Measure (POEM) questionnaire
timeFrame: Baseline to Month 120
measure: Dermatology Life Quality Index
timeFrame: Baseline to Month 120
measure: Bullous Pemphigoid Disease Area Index(BPDAI)
timeFrame: Baseline to Month 120
measure: Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
timeFrame: Baseline to Month 120
measure: Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)
timeFrame: Baseline to Month 120
measure: Urticaria Activity Score 7a （UAS7a）
timeFrame: Baseline to Month 120
measure: Urticaria Control test (UCT)
timeFrame: Baseline to Month 120
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: