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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05316805
Acronym
CORNERSTONE
Enrollment
100000
Registered
2022-04-07
Start date
2021-08-31
Completion date
2031-12-31
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis Eczema, Prurigo Nodularis

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.

Interventions

None listed

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DemographicsbaselineAge, sex, ethnicity, body weight and height
Age at Type 2 skin disease onsetbaselineAge of study patients at time of Type 2 skin disease onset
Type of current Type 2 skin disease therapyBaselineType of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)
Presence of Type 2 skin disease and selected comorbid conditionsBaseline to Month 120Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study

Secondary

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

Countries

China

Contacts

Primary ContactYang Wang, Doctor
yangwang_dr@bjmu.edu.cn008613811232795

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026