NCT04509570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3.7 years

First QC Date

July 28, 2020

Last Update Submit

July 18, 2024

Conditions

Autoimmune Bullous Disease

Keywords

ELS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The presence or absence of ectopic-lymph node-like structure by histologic evaluation

    through study completion, an average of 1 year

Study Arms (1)

Treatment: ILI(Intralesional injection)

OTHER

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

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

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

Also known as: Steroid injection
Treatment: ILI(Intralesional injection)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>
  • Adults over 19
  • Patietns who voluntarily signed the consent form
  • Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
  • 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\>
  • 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
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Han D, Lee AY, Kim T, Choi JY, Cho MY, Song A, Kim C, Shim JH, Kim HJ, Kim H, D'Angio HB, Preska R, Mayer AT, Kim M, Choi EJ, Kim TG, Shin EC, Park K, Kim DY, Kim SC, Kim JH. Microenvironmental network of clonal CXCL13+CD4+ T cells and Tregs in pemphigus chronic blisters. J Clin Invest. 2023 Dec 1;133(23):e166357. doi: 10.1172/JCI166357.

    PMID: 37815865DERIVED

MeSH Terms

Interventions

BiopsySteroids

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 12, 2020

Study Start

February 8, 2019

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

KR(1)