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NCT Number: NCT05316805

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

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.

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Key information

Conditions

Atopic Dermatitis Eczema Prurigo Nodularis

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Wang, Doctor

CONTACT

[email protected]

008613811232795

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Acronym: CORNERSTONE

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Apr 7, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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