Retrospective Study of the Effects of Sub-pathologic Phenotypes of BP on Clinical Management and Prognosis

Bullous Pemphigoid Clinical Trial

— BP  

Official title:

A Retrospective Study of the Effects of Different Pathologic Phenotypes of Bullous Pemphigoid on Clinical Management and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213909
• Other study ID #: XijingH-PF-KY20232420-C-1
• Status: Recruiting
• Start date: January 11, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Xijing Hospital
• Contact: Shuai Shao, Phd
• Phone: +862984775401
• Email: 857746654[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bullous pemphigoid (BP) is a chronic autoimmune subepidermal blistering disease primarily affecting the elderly with a significant risk of mortality and morbidity. Various inflammatory cells such as eosinophils, lymphocytes, neutrophils and their granulopoiesis play an important role in the pathogenesis of BP. Infiltration of peripheral blood eosinophils, lymphocytes, and neutrophils into the skin is considered a major feature of BP, making it a heterogeneous disease with different histologic and clinical subtypes. This clinical study was conducted to further investigate the impact of different pathologic phenotypes of BP on the treatment and prognosis of the disease. A retrospective epidemiologic investigative approach was used，and case collection included demographic information, medical history, clinical manifestations, and histopathologic features. Including gender, age, duration of disease, number of days of hospitalization, mucosal involvement, clinical diagnosis before admission, histopathological diagnosis, laboratory tests, concomitant diseases, treatment and its changes in laboratory indexes before and after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

Inclusion Criteria:

• (1) Patients with Bullous Pemphigoid who were first hospitalized in the Department of Dermatology of Xijing Hospital
• (2) Age 0-100 years old, gender is not limited.
• (3) Diagnosis is confirmed by clinical, histopathologic, immunopathologic and/or anti-BP180 antibody tests.
• (4) Complete skin histopathology information

Exclusion Criteria:

• (1) Patients with Bullous Pemphigoid who were not first diagnosed in our hospital.
• (2) Those who have received systemic glucocorticoid, immunosuppressant, biologic, or other drug therapy within the past month.

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Other:
• This is a retrospective analysis of health data from inpatient record, no intervention was designed
This is a retrospective analysis of health data from inpatient record, no intervention was designed

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bullous Pemphigoid Disease Area Index (BPDAI) severity score	We use BPDAI severity score as measure tool	10 years