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临床试验/NCT04509570
NCT04509570已完成不适用

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

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 41 人开始时间: 2019年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Clinical outcome: size of lesions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • <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.

排除标准

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

结局指标

主要结局

Clinical outcome: size of lesions

时间窗: through study completion, an average of 1 year

The area of the lesions will be measured using the Image J program

次要结局

  • The presence or absence of ectopic-lymph node-like structure by histologic evaluation(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Hoon Kim, MD, PhD

Associate Professor

Gangnam Severance Hospital

研究点 (2)

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