Bullous PemphigoidBPNCT06213909
Retrospective Study of the Effects of Sub-pathologic Phenotypes of BP on Clinical Management and Prognosis
An observational study of Bullous Pemphigoid, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Bullous Pemphigoid
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- (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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Wang, Prof
About this study
Official title: 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.
- Conditions
- Bullous Pemphigoid
- Being tested
- This is a retrospective analysis of health data from inpatient record, no intervention was designed
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a retrospective analysis of health data from inpatient record, no intervention was designedOther
This is a retrospective analysis of health data from inpatient record, no intervention was designed
| Study group | Role | What they receive |
|---|---|---|
| eosinophil group | Based on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly eosinophils Receives: 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 Receives: 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 Receives: Other: This is a retrospective analysis of health data from inpatient record, no intervention was designed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bullous Pemphigoid Disease Area Index (BPDAI) severity score
We use BPDAI severity score as measure tool
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start11 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Phd, Principal investigator, Dermatology Department of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213909
- Sponsor's protocol ID
- XijingH-PF-KY20232420-C-1
- Acronym
- BP
- Status last verified
- Dec 2023
- First submitted
- 10 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Effects of Different Pathologic Phenotypes of Bullous Pemphigoid on Clinical Management and Prognosis
- ClinicalTrials.gov ID
- NCT06213909
- Acronym / sponsor ID
- BP / XijingH-PF-KY20232420-C-1
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 11 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Jan 2024 (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 (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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eosinophil group | – | Other: This is a retrospective analysis of health data from inpatient record, no intervention was designedBased on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly eosinophils |
| neutrophil group | – | Other: This is a retrospective analysis of health data from inpatient record, no intervention was designedBased on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly neutrophil |
| lymphocyte group | – | Other: This is a retrospective analysis of health data from inpatient record, no intervention was designedBased on the histopathologic phenotype of the patient's skin, the inflammatory cells infiltrating within and around the blisters were predominantly lymphocyte |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (2 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a retrospective analysis of health data from inpatient record, no intervention was designedThis is a retrospective analysis of health data from inpatient record, no intervention was designed | Other | eosinophil group, lymphocyte group, neutrophil group |
Primary outcome
Bullous Pemphigoid Disease Area Index (BPDAI) severity score
Time frame: 10 years
We use BPDAI severity score as measure tool
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Yes
Related trials for Bullous Pemphigoid
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
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)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
Bullous Pemphigoid (BP)
Active, not recruitingPhase 3
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
Severe Forms of Mucous Membrane Pemphigoid
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.
Gang Wang, Phd principal investigator
Dermatology Department of Xijing 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, run by Xijing Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuai Shao, Phd (+862984775401, 857746654@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bullous Pemphigoid Disease Area Index (BPDAI) severity score (time frame: 10 years). 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 19 Jan 2024.