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

NCT06213909 | Unknown

• 1 other identifier: XijingH-PF-KY20232420-C-1
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Bullous Pemphigoid Disease Area Index (BPDAI) severity score

  We use BPDAI severity score as measure tool

  10 years

Study Arms (3)

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

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

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

Interventions

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

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

eosinophil group; lymphocyte group; neutrophil group

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gang Wang, Phd

  Dermatology Department of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuai Shao, Phd

CONTACT

+862984775401; 857746654@qq.com

Chen Yu, Phd

CONTACT

+862984775401; ycyc_2005@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 11, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)