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Clinical Trials/NCT04509570
NCT04509570
Completed
Not Applicable

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

Gangnam Severance Hospital1 site in 1 country41 target enrollmentFebruary 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autoimmune Bullous Disease
Sponsor
Gangnam Severance Hospital
Enrollment
41
Locations
1
Primary Endpoint
Clinical outcome: size of lesions
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2019
End Date
October 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hoon Kim, MD, PhD

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

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:

Exclusion Criteria

  • Patients who do not meet the criteria for autoimmune bullous disease

Outcomes

Primary Outcomes

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 Outcomes

  • The presence or absence of ectopic-lymph node-like structure by histologic evaluation(through study completion, an average of 1 year)

Study Sites (1)

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