Bullous Pemphigoid (BP)BP-EPICNCT07649486
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
An observational study of Bullous Pemphigoid (BP), run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid (BP)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 25 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi
Istanbul, FATİH, 34096
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Bullous Pemphigoid (BP)
- Keywords
- bullous pemphigoid (BP), Periostin, Eosinophilic Catyonic Protein, BPDAI, IgE, Eosinophilia, Autoimmune Blistering Disease
- Medical subject headings
- Pemphigoid, Bullous, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (retrospective assessment of existing clinical and histopathological data)
Secondary outcomes (7)
Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels
Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and serum total IgE levels (IU/mL) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Peripheral Blood Eosinophil Count
Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and peripheral blood eosinophil count (cells/µL) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
Correlation Between Periostin Expression and Disease Relapse Frequency
Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and disease relapse frequency (number of relapses) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical and histopathological data
Correlation Between Periostin Immunohistochemical Expression and Hospitalization History
Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and hospitalization history (yes/no) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between Eosinophilic Cationic Protein Expression and Disease Relapse Frequency
Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and disease relapse frequency (number of relapses) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Hospitalization History
Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and hospitalization history (yes/no) in patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between BPDAI Score and Eosinophilic Cationic Protein Expression
Correlation between BPDAI disease activity score and tissue eosinophilic cationic protein (ECP) expression assessed by immunohistochemistry using a semiquantitative 0-3 staining score in skin biopsy specimens from patients with bullous pemphigoid.
Measured: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start4 May 2026
- Primary completion24 Dec 2026 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous Pemphigoid (BP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MURAT OZKAN, Istanbul Training and Research Hospital
- Investigators
- Ayse Esra Koku Aksu, Prof.Dr., Study chair, University of Health Sciences, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649486
- Sponsor's protocol ID
- SBU-IEAH-KAEK-20262404-26
- Acronym
- BP-EPIC
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This retrospective, single-center study uses patient data collected as part of routine clinical care. Data sharing is restricted due to institutional policies, ethical considerations, and patient confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07649486
- Acronym / sponsor ID
- BP-EPIC / SBU-IEAH-KAEK-20262404-26
- Conditions
- Bullous Pemphigoid (BP)
- Keywords
- bullous pemphigoid (BP), Periostin, Eosinophilic Catyonic Protein, BPDAI, IgE, Eosinophilia, Autoimmune Blistering Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 4 May 2026 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels
Time frame: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Peripheral Blood Eosinophil Count
Time frame: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
Correlation Between Periostin Expression and Disease Relapse Frequency
Time frame: Baseline (retrospective assessment of existing clinical and histopathological data
Correlation Between Periostin Immunohistochemical Expression and Hospitalization History
Time frame: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between Eosinophilic Cationic Protein Expression and Disease Relapse Frequency
Time frame: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Hospitalization History
Time frame: Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between BPDAI Score and Eosinophilic Cationic Protein Expression
Time frame: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This retrospective, single-center study uses patient data collected as part of routine clinical care. Data sharing is restricted due to institutional policies, ethical considerations, and patient confidentiality requirements.
Related trials for Bullous Pemphigoid (BP)
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Not yet recruitingPhase 3
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
Bullous Pemphigoid (BP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Esra Koku Aksu, Prof.Dr. study chair
University of Health Sciences, Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid (BP), run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between BPDAI Score and Periostin Immunohistochemical Expression (time frame: Baseline (retrospective assessment of existing clinical and histopathological data)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.