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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bullous Pemphigoid
• Intervention / Treatment: Other: This is a retrospective analysis of health data from inpatient record, no intervention was designed

• Study Type: Observational
• Enrollment (Estimated): 318

Contacts and Locations

• Study Contact: Name: Shuai Shao, Phd; Phone Number: +862984775401; Email: 857746654@qq.com
• Study Contact Backup: Name: Chen Yu, Phd; Phone Number: +862984775401; Email: ycyc_2005@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Gang Wang, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We included patients with BP who were first admitted to the Department of Dermatology of Xijing Hospital with a clear diagnosis, complete information on skin histopathology slides, and were of any gender and age.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eosinophil group; Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly eosinophils	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
neutrophil group; Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly neutrophil	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
lymphocyte group; Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly lymphocyte	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bullous Pemphigoid Disease Area Index (BPDAI) severity score	We use BPDAI severity score as measure tool	10 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Gang Wang, Phd, Dermatology Department of Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 11, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Pemphigoid, Bullous
• Other Study ID Numbers: XijingH-PF-KY20232420-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No