Atopic Dermatitis EczemaCORNERSTONENCT05316805
China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project
An observational study of Atopic Dermatitis Eczema and Prurigo Nodularis, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis Eczema, Prurigo Nodularis
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2021to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit)
Who may be able to join
- 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).
Who cannot join
- patients who fail to provide informed consent form;
- patients who cannot complete the questionnaire independently or under the guidance of investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Yang Wang, Doctor, 008613811232795, yangwang_dr@bjmu.edu.cn
About this study
Official title: China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study
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.
- Conditions
- Atopic Dermatitis Eczema, Prurigo Nodularis
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Age, sex, ethnicity, body weight and height
Measured: baseline
Age at Type 2 skin disease onset
Age of study patients at time of Type 2 skin disease onset
Measured: baseline
Type of current Type 2 skin disease therapy
Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)
Measured: Baseline
Presence of Type 2 skin disease and selected comorbid conditions
Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study
Measured: Baseline to Month 120
Secondary outcomes (10)
Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
Measured: Baseline to Month 120
Eczema Area and Severity Index (EASI)
EASI score as assessed by physician
Measured: Baseline to Month 120
Body Surface Area (BSA) percentage affected by Type 2 skin disease
BSA score as assessed by physician
Measured: Baseline to Month 120
Patient Oriented Eczema Measure (POEM) questionnaire
POEM score as reported by the participant's caregiver
Measured: Baseline to Month 120
Dermatology Life Quality Index
DLQI score as reported by the patients or caregivers
Measured: Baseline to Month 120
Bullous Pemphigoid Disease Area Index(BPDAI)
BPDAI score as assessed by physician
Measured: Baseline to Month 120
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
ABSIS score as assessed by physician
Measured: Baseline to Month 120
Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)
CU-Q2oL score as assessed by patients or caregivers
Measured: Baseline to Month 120
Urticaria Activity Score 7a （UAS7a）
UAS7a score as assessed by physician
Measured: Baseline to Month 120
Urticaria Control test (UCT)
UCT score as assessed by patients or caregivers
Measured: Baseline to Month 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start31 Aug 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316805
- Sponsor's protocol ID
- PKU202108
- Acronym
- CORNERSTONE
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao J, Zhang Z, Chen H, Dou X, Zhao Z, Liu L, Wang Y, Li H. Associations of demographics, aggravating factors, comorbidities, and treatments with atopic dermatitis severity in China: A national cross-sectional study. Chin Med J (Engl). 2024 Mar 3;138(5):553-561. doi: 10.1097/CM9.0000000000003042. Epub 2024 Mar 3.
PubMed 38431766
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05316805
- Acronym / sponsor ID
- CORNERSTONE / PKU202108
- Conditions
- Atopic Dermatitis Eczema, Prurigo Nodularis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- patients who fail to provide informed consent form;
- patients who cannot complete the questionnaire independently or under the guidance of investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics
Time frame: baseline
Age, sex, ethnicity, body weight and height
Age at Type 2 skin disease onset
Time frame: baseline
Age of study patients at time of Type 2 skin disease onset
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)
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
10 secondary outcomes
Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
Time frame: Baseline to Month 120
Eczema Area and Severity Index (EASI)
Time frame: Baseline to Month 120
Body Surface Area (BSA) percentage affected by Type 2 skin disease
Time frame: Baseline to Month 120
Patient Oriented Eczema Measure (POEM) questionnaire
Time frame: Baseline to Month 120
Dermatology Life Quality Index
Time frame: Baseline to Month 120
Bullous Pemphigoid Disease Area Index(BPDAI)
Time frame: Baseline to Month 120
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Time frame: Baseline to Month 120
Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)
Time frame: Baseline to Month 120
Urticaria Activity Score 7a （UAS7a）
Time frame: Baseline to Month 120
Urticaria Control test (UCT)
Time frame: Baseline to Month 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 38431766Zhao J, Zhang Z, Chen H, Dou X, Zhao Z, Liu L, Wang Y, Li H. Associations of demographics, aggravating factors, comorbidities, and treatments with atopic dermatitis severity in China: A national cross-sectional study. Chin Med J (Engl). 2024 Mar 3;138(5):553-561. doi: 10.1097/CM9.0000000000003042. Epub 2024 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis Eczema and Prurigo Nodularis, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang, Doctor (008613811232795, yangwang_dr@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05316805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.