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

Not Applicable

Completed

• Conditions: Autoimmune Bullous Disease
• Interventions: Procedure: Biopsy

• Registration Number: NCT04509570
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-08
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-09
• Study First Posted: 2020-08-12
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical outcome: size of lesions	through study completion, an average of 1 year	The area of the lesions will be measured using the Image J program

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of