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A Prospective & Retrospective Study on Ectopic Lymphoid-like Structures in Chronic Skins of Autoimmune Bullous Diseases

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04509570
Enrollment
41
Registered
2020-08-12
Start date
2019-02-08
Completion date
2022-10-31
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Bullous Disease

Keywords

ELS

Brief 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. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.

Interventions

PROCEDUREBiopsy

5\ 20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\> Prospective study Inclusion Criteria: 1. Adults over 19 2. Patietns who voluntarily signed the consent form 3. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests Retrospective study Inclusion Criteria: 1. Samples in human-derived banks from March 2013 to October 2018 2. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests 3. Adults over 19 \<Treatment of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\> Prospective study Inclusion Criteria: 1. Adults over 19 2. Patients who voluntarily signed the consent form 3. Patients who have skin lesions harboring ectopic lymph node-like structure in a prospective or retrospective manner 4. Patients who have chronic lesions sustained for more than 4 months during the treatment of systemic corticosteroids Retrospective study Inclusion Criteria: 1. Patients who have skin lesions harboring ectopic lymph node-like structure in a retrospective manner 2. Paitents who have been treated for intralesional steroid injection 3. Patients who have data of photography to compare the clinical effects before and after intralesional corticosteroid treatment.

Exclusion criteria

1\. Patients who do not meet the criteria for autoimmune bullous disease

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcome: size of lesionsthrough study completion, an average of 1 yearThe area of the lesions will be measured using the Image J program

Secondary

MeasureTime frameDescription
The presence or absence of ectopic-lymph node-like structure by histologic evaluationthrough study completion, an average of 1 yearThe presence of absence of ectopic-lymph node-like structure will be evaluated by histologic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026