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

Atopic Dermatitis Eczema Clinical Trial

— CORNERSTONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316805
• Other study ID #: PKU202108
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: March 2022
• Source: Peking University First Hospital
• Contact: Yang Wang, Doctor
• Phone: 008613811232795
• Email: yangwang_dr[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Prurigo
• Prurigo Nodularis
• Skin Diseases

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Age, sex, ethnicity, body weight and height	baseline
Primary	Age at Type 2 skin disease onset	Age of study patients at time of Type 2 skin disease onset	baseline
Primary	Type of current Type 2 skin disease therapy	Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)	Baseline
Primary	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	Baseline to Month 120
Secondary	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	Baseline to Month 120
Secondary	Eczema Area and Severity Index (EASI)	EASI score as assessed by physician	Baseline to Month 120
Secondary	Body Surface Area (BSA) percentage affected by Type 2 skin disease	BSA score as assessed by physician	Baseline to Month 120
Secondary	Patient Oriented Eczema Measure (POEM) questionnaire	POEM score as reported by the participant's caregiver	Baseline to Month 120
Secondary	Dermatology Life Quality Index	DLQI score as reported by the patients or caregivers	Baseline to Month 120
Secondary	Bullous Pemphigoid Disease Area Index(BPDAI)	BPDAI score as assessed by physician	Baseline to Month 120
Secondary	Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)	ABSIS score as assessed by physician	Baseline to Month 120
Secondary	Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)	CU-Q2oL score as assessed by patients or caregivers	Baseline to Month 120
Secondary	Urticaria Activity Score 7a (UAS7a)	UAS7a score as assessed by physician	Baseline to Month 120
Secondary	Urticaria Control test (UCT)	UCT score as assessed by patients or caregivers	Baseline to Month 120