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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • Other: Treatment: ILI(Intralesional injection)
    • 5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • The presence or absence of ectopic-lymph node-like structure by histologic evaluation
    • Time Frame: through study completion, an average of 1 year
    • The presence of absence of ectopic-lymph node-like structure will be evaluated by histologic evaluation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gangnam Severance Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jong Hoon Kim, MD, PhD, Associate Professor – Gangnam Severance Hospital

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