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NCT Number: NCT04509570

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

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.

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Key information

Conditions

Autoimmune Bullous Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Retrospective study Inclusion Criteria:

  • 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.

Exclusion criteria

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

Treatment and study plan

Biopsy

Procedure

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

Other names: Steroid injection

Primary outcomes

  1. 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

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

    Time frame: through study completion, an average of 1 year

    The presence of absence of ectopic-lymph node-like structure will be evaluated by histologic evaluation

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2020
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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