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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Autoimmune Bullous Disease

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <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: 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. Exclusion Criteria: 1. Patients who do not meet the criteria for autoimmune bullous disease

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment: ILI(Intralesional injection)<br>5 20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared | Procedure: Biopsy<br>* 5 20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared<br>* Other names: Steroid injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: size of lesions | The area of the lesions will be measured using the Image J program | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELS