Correlation of Disease Severity With Histopathological Features, Serum IgE Levels, Eosinophil Count, and Tissue Expression of Eosinophilic Cationic Protein and Periostin in Patients With Bullous Pemphigoid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Correlation Between BPDAI Score and Periostin Immunohistochemical Expression
Study Overview
Brief Summary
Bullous pemphigoid is an autoimmune subepidermal blistering disease characterized by eosinophilic inflammation and variable disease severity. This retrospective observational study aims to evaluate the relationship between disease severity and histopathological features, serum IgE levels, peripheral eosinophil counts, and the expression of eosinophilic cationic protein (ECP) and periostin in skin biopsy specimens of patients with bullous pemphigoid.
Immunohistochemical staining for ECP and periostin will be assessed semi-quantitatively and correlated with clinical and laboratory parameters, including BPDAI scores, eosinophil counts, serum IgE levels, hospitalization history, and disease relapse. The study seeks to identify potential tissue biomarkers associated with disease activity and severity in bullous pemphigoid.
Detailed Description
Bullous pemphigoid (BP) is the most common autoimmune subepidermal blistering disease and is characterized by autoantibodies directed against hemidesmosomal proteins. Eosinophils and eosinophil-associated mediators are believed to play a central role in disease pathogenesis. Periostin and eosinophilic cationic protein (ECP) have been implicated in eosinophilic inflammation; however, their relationship with clinical disease severity in BP remains incompletely understood.
This single-center retrospective observational study will include patients diagnosed with bullous pemphigoid at the University of Health Sciences, Istanbul Training and Research Hospital. Clinical, laboratory, and histopathological data will be collected from medical records.
The study will evaluate demographic characteristics, disease severity measured by BPDAI, serum IgE levels, peripheral eosinophil counts, hospitalization history, relapse frequency, and other clinicopathological parameters. Archived skin biopsy specimens will undergo immunohistochemical staining for periostin and ECP. Staining intensity will be assessed using semi-quantitative scoring methods and correlated with clinical and laboratory findings.
The primary objective is to determine whether periostin and ECP expression levels are associated with disease severity. Secondary objectives include evaluating correlations between tissue biomarker expression and serum IgE levels, eosinophil counts, hospitalization, and disease recurrence.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Diagnosis of bullous pemphigoid confirmed by compatible clinical, histopathological, and/or direct immunofluorescence findings.
- •Availability of archived skin biopsy specimens suitable for immunohistochemical evaluation of periostin and eosinophilic cationic protein (ECP).
- •Availability of clinical and laboratory data, including BPDAI score, serum IgE level, and peripheral eosinophil count.
Exclusion Criteria
- •Age <18 years.
- •Diagnosis other than bullous pemphigoid.
- •Inadequate or unavailable biopsy specimens for immunohistochemical analysis.
- •Missing clinical, histopathological, or laboratory data required for study analyses.
Arms & Interventions
Bullous Pemphigoid Patients
Patients with bullous pemphigoid included in a retrospective observational study evaluating the relationship between disease severity and periostin and ECP expression in skin biopsy specimens.
Outcomes
Primary Outcomes
Correlation Between BPDAI Score and Periostin Immunohistochemical Expression
Time Frame: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation between BPDAI disease activity score and periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens from patients with bullous pemphigoid.
Secondary Outcomes
- Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels(Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
- Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Peripheral Blood Eosinophil Count(Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data))
- Correlation Between Periostin Expression and Disease Relapse Frequency(Baseline (retrospective assessment of existing clinical and histopathological data)
- Correlation Between Periostin Immunohistochemical Expression and Hospitalization History(Baseline (retrospective assessment of existing clinical and histopathological data))
- Correlation Between Eosinophilic Cationic Protein Expression and Disease Relapse Frequency(Baseline (retrospective assessment of existing clinical and histopathological data))
- Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Hospitalization History(Baseline (retrospective assessment of existing clinical and histopathological data))
- Correlation Between BPDAI Score and Eosinophilic Cationic Protein Expression(Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data))
Investigators
MURAT OZKAN
Dermatology Specialist
Istanbul Training and Research Hospital