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

Recruiting

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

• Registration Number: NCT06213909
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study Start: 2024-01-11
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 318

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lymphocyte group	This is a retrospective analysis of health data from inpatient record, no intervention was designed	Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly lymphocyte
eosinophil group	This is a retrospective analysis of health data from inpatient record, no intervention was designed	Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly eosinophils
neutrophil group	This is a retrospective analysis of health data from inpatient record, no intervention was designed	Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly neutrophil

Primary Outcome Measures

Name	Time	Method
Bullous Pemphigoid Disease Area Index (BPDAI) severity score	10 years	We use BPDAI severity score as measure tool

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China