Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)

NCT07649486 | Active Not Recruiting

• 1 other identifier: SBU-IEAH-KAEK-20262404-26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid (BP)

Keywords

bullous pemphigoid (BP); Periostin; Eosinophilic Catyonic Protein; BPDAI; IgE; Eosinophilia; Autoimmune Blistering Disease

Outcome Measures

Primary Outcomes (1)

• Correlation Between BPDAI Score and Periostin Immunohistochemical Expression

  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.

  Baseline (retrospective assessment of existing clinical and histopathological data)

Secondary Outcomes (7)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with bullous pemphigoid and followed at the University of Health Sciences, Istanbul Training and Research Hospital. Participants will be identified retrospectively from hospital records and pathology archives. Clinical, laboratory, and histopathological data, including BPDAI scores, serum IgE levels, peripheral eosinophil counts, and immunohistochemical expression of periostin and eosinophilic cationic protein, will be evaluated.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi

Istanbul, FATİH, 34096, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archived formalin-fixed paraffin-embedded (FFPE) skin biopsy specimens obtained from patients with bullous pemphigoid. Samples will be used for immunohistochemical evaluation of periostin and eosinophilic cationic protein (ECP). No DNA extraction will be performed.

MeSH Terms

Conditions

Pemphigoid, Bullous; Eosinophilia

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ayse Esra Koku Aksu, Prof.Dr.

  University of Health Sciences, Istanbul Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Specialist

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): April 25, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)