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

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 Overview

• Status: Completed
• Conditions: Autoimmune Bullous Disease
• Intervention / Treatment: Procedure: Biopsy

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeverance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ELS
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Tertiary Lymphoid Structures
• Other Study ID Numbers: 3-2018-0302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No