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RecruitingNCT05316805CORNERSTONEUpdated Aug 15, 2024

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

An observational study in Atopic Dermatitis Eczema and Prurigo Nodularis, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Started Aug 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,000
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis Eczema
  • Prurigo Nodularis
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. patients who fail to provide form;
  2. patients who cannot complete the questionnaire independently or under the guidance of investigators
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Demographics

    Age, sex, ethnicity, body weight and height

    Time frame: baseline

  2. Age at Type 2 skin disease onset

    Age of study patients at time of Type 2 skin disease onset

    Time frame: baseline

  3. Type of current Type 2 skin disease therapy

    Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)

    Time frame: Baseline

  4. 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

    Time frame: Baseline to Month 120

Secondary outcomes

  1. 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

    Time frame: Baseline to Month 120

  2. Eczema Area and Severity Index (EASI)

    EASI score as assessed by physician

    Time frame: Baseline to Month 120

  3. Body Surface Area (BSA) percentage affected by Type 2 skin disease

    BSA score as assessed by physician

    Time frame: Baseline to Month 120

  4. Patient Oriented Eczema Measure (POEM) questionnaire

    POEM score as reported by the participant's caregiver

    Time frame: Baseline to Month 120

  5. Dermatology Life Quality Index

    DLQI score as reported by the patients or caregivers

    Time frame: Baseline to Month 120

  6. Bullous Pemphigoid Disease Area Index(BPDAI)

    BPDAI score as assessed by physician

    Time frame: Baseline to Month 120

  7. Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)

    ABSIS score as assessed by physician

    Time frame: Baseline to Month 120

  8. Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)

    CU-Q2oL score as assessed by patients or caregivers

    Time frame: Baseline to Month 120

  9. Urticaria Activity Score 7a (UAS7a)

    UAS7a score as assessed by physician

    Time frame: Baseline to Month 120

  10. Urticaria Control test (UCT)

    UCT score as assessed by patients or caregivers

    Time frame: Baseline to Month 120

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Dec 2031, 124 months after the start.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 124 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2022
First posted
Apr 7, 2022
StartActual
Aug 31, 2021
Primary completionEst.
Dec 31, 2031
CompletionEst.
Dec 31, 2031
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05316805
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Aug 31, 2021
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Aug 15, 2024

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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