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

Recruiting

• Conditions: Atopic Dermatitis Eczema; Prurigo Nodularis

• Registration Number: NCT05316805
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Age at Type 2 skin disease onset	baseline	Age of study patients at time of Type 2 skin disease onset
Presence of Type 2 skin disease and selected comorbid conditions	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
Demographics	baseline	Age, sex, ethnicity, body weight and height
Type of current Type 2 skin disease therapy	Baseline	Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)

Secondary Outcome Measures

Name	Time	Method
Patient Oriented Eczema Measure (POEM) questionnaire	Baseline to Month 120	POEM score as reported by the participant's caregiver
Dermatology Life Quality Index	Baseline to Month 120	DLQI score as reported by the patients or caregivers
Eczema Area and Severity Index (EASI)	Baseline to Month 120	EASI score as assessed by physician
Body Surface Area (BSA) percentage affected by Type 2 skin disease	Baseline to Month 120	BSA score as assessed by physician
Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies	Baseline to Month 120	Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)	Baseline to Month 120	ABSIS score as assessed by physician
Urticaria Activity Score 7a （UAS7a）	Baseline to Month 120	UAS7a score as assessed by physician
Urticaria Control test (UCT)	Baseline to Month 120	UCT score as assessed by patients or caregivers
Bullous Pemphigoid Disease Area Index(BPDAI)	Baseline to Month 120	BPDAI score as assessed by physician
Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)	Baseline to Month 120	CU-Q2oL score as assessed by patients or caregivers

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China