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

NCT ID: NCT04509570

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Autoimmune Bullous Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment: ILI(Intralesional injection)

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

Group Type OTHER

Biopsy

Intervention Type PROCEDURE

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

Interventions

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Biopsy

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

Intervention Type PROCEDURE

Other Intervention Names

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Steroid injection

Eligibility Criteria

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Inclusion Criteria

\<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>


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


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\>


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


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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jong Hoon Kim, MD, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 37815865 (View on PubMed)

Other Identifiers

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3-2018-0302

Identifier Type: -

Identifier Source: org_study_id

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