Autoimmune Bullous DiseaseNCT04509570
A Prospective & Retrospective Study on Ectopic Lymphoid-like Structures in Chronic Skins of Autoimmune Bullous Diseases
A study testing Biopsy in people with Autoimmune Bullous Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Autoimmune Bullous Disease
- What is being tested?
- Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2019to 31 Oct 2022
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients>
- Prospective study Inclusion Criteria:
- Adults over 19
- Patietns who voluntarily signed the consent form
- Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
- Retrospective study Inclusion Criteria:
Show all 18Show fewer
- Samples in human-derived banks from March 2013 to October 2018
- Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
- Adults over 19 <Treatment of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients>
- Prospective study Inclusion Criteria:
- Adults over 19
- Patients who voluntarily signed the consent form
- Patients who have skin lesions harboring ectopic lymph node-like structure in a prospective or retrospective manner
- Patients who have chronic lesions sustained for more than 4 months during the treatment of systemic corticosteroids
- Retrospective study Inclusion Criteria:
- Patients who have skin lesions harboring ectopic lymph node-like structure in a retrospective manner
- Paitents who have been treated for intralesional steroid injection
- Patients who have data of photography to compare the clinical effects before and after intralesional corticosteroid treatment.
Who cannot join
- 1. Patients who do not meet the criteria for autoimmune bullous disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective & Retrospective Study on the Presence of Ectopic Lymphoid-like Structures and Intralesional Steroid Injection for the Chronic Skin Lesion of Autoimmune Bullous Disease Patients
The purpose of this study is to identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.
- Conditions
- Autoimmune Bullous Disease
- Being tested
- Biopsy
- Keywords
- ELS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Steroid injection
5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared
| Study group | Role | What they receive |
|---|---|---|
| Treatment: ILI(Intralesional injection) | Other | 5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome: size of lesions
The area of the lesions will be measured using the Image J program
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The presence or absence of ectopic-lymph node-like structure by histologic evaluation
The presence of absence of ectopic-lymph node-like structure will be evaluated by histologic evaluation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start8 Feb 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Bullous DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hoon Kim, MD, PhD, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509570
- Sponsor's protocol ID
- 3-2018-0302
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2020
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han D, Lee AY, Kim T, Choi JY, Cho MY, Song A, Kim C, Shim JH, Kim HJ, Kim H, D'Angio HB, Preska R, Mayer AT, Kim M, Choi EJ, Kim TG, Shin EC, Park K, Kim DY, Kim SC, Kim JH. Microenvironmental network of clonal CXCL13+CD4+ T cells and Tregs in pemphigus chronic blisters. J Clin Invest. 2023 Dec 1;133(23):e166357. doi: 10.1172/JCI166357.
PubMed 37815865
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective & Retrospective Study on the Presence of Ectopic Lymphoid-like Structures and Intralesional Steroid Injection for the Chronic Skin Lesion of Autoimmune Bullous Disease Patients
- ClinicalTrials.gov ID
- NCT04509570
- Acronym / sponsor ID
- 3-2018-0302
- Conditions
- Autoimmune Bullous Disease
- Keywords
- ELS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Aug 2020 (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.
The purpose of this study is to identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: ILI(Intralesional injection) | Other | Procedure: Biopsy5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- <Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients>
- Adults over 19
- Patietns who voluntarily signed the consent form
- Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
- Samples in human-derived banks from March 2013 to October 2018
Key exclusion criteria (1 listed)
- 1. Patients who do not meet the criteria for autoimmune bullous disease
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 |
|---|---|---|
| BiopsyAlso: Steroid injection5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared | Procedure or surgery | Treatment: ILI(Intralesional injection) |
Primary outcome
Clinical outcome: size of lesions
Time frame: through study completion, an average of 1 year
The area of the lesions will be measured using the Image J program
1 secondary outcome
The presence or absence of ectopic-lymph node-like structure by histologic evaluation
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 37815865Han D, Lee AY, Kim T, Choi JY, Cho MY, Song A, Kim C, Shim JH, Kim HJ, Kim H, D'Angio HB, Preska R, Mayer AT, Kim M, Choi EJ, Kim TG, Shin EC, Park K, Kim DY, Kim SC, Kim JH. Microenvironmental network of clonal CXCL13+CD4+ T cells and Tregs in pemphigus chronic blisters. J Clin Invest. 2023 Dec 1;133(23):e166357. doi: 10.1172/JCI166357.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Autoimmune Bullous Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
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 18 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcome: size of lesions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509570, which also lists 1 linked publication.
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 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.