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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05316805
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University First Hospital

Study Description
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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
Atopic Dermatitis Eczema Prurigo Nodularis

Study Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Demographics [ Time Frame: baseline ]
    Age, sex, ethnicity, body weight and height

  2. Age at Type 2 skin disease onset [ Time Frame: baseline ]
    Age of study patients at time of Type 2 skin disease onset

  3. Type of current Type 2 skin disease therapy [ Time Frame: Baseline ]
    Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)

  4. Presence of Type 2 skin disease and selected comorbid conditions [ Time Frame: 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 :
  1. Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies [ Time Frame: Baseline to Month 120 ]
    Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies

  2. Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Month 120 ]
    EASI score as assessed by physician

  3. Body Surface Area (BSA) percentage affected by Type 2 skin disease [ Time Frame: Baseline to Month 120 ]
    BSA score as assessed by physician

  4. Patient Oriented Eczema Measure (POEM) questionnaire [ Time Frame: Baseline to Month 120 ]
    POEM score as reported by the participant's caregiver

  5. Dermatology Life Quality Index [ Time Frame: Baseline to Month 120 ]
    DLQI score as reported by the patients or caregivers

  6. Bullous Pemphigoid Disease Area Index(BPDAI) [ Time Frame: Baseline to Month 120 ]
    BPDAI score as assessed by physician

  7. Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [ Time Frame: Baseline to Month 120 ]
    ABSIS score as assessed by physician

  8. Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) [ Time Frame: Baseline to Month 120 ]
    CU-Q2oL score as assessed by patients or caregivers

  9. Urticaria Activity Score 7a （UAS7a） [ Time Frame: Baseline to Month 120 ]
    UAS7a score as assessed by physician

  10. Urticaria Control test (UCT) [ Time Frame: Baseline to Month 120 ]
    UCT score as assessed by patients or caregivers


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05316805


Contacts
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Contact: Yang Wang, Doctor 008613811232795 yangwang_dr@bjmu.edu.cn

Locations
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China
Peking University First Hospital Recruiting
Beijing, China
Contact: Yang Wang, Doctor    008613811232795    yangwang_dr@bjmu.edu.cn   
Sponsors and Collaborators
Peking University First Hospital
More Information
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Responsible Party: Peking University First Hospital
ClinicalTrials.gov Identifier: NCT05316805    
Other Study ID Numbers: PKU202108
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Skin Diseases
Prurigo