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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 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
- 否
入选标准
- •\ 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 \ 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.
排除标准
- •1. Patients who do not meet the criteria for autoimmune bullous disease
研究组 & 干预措施
Treatment: ILI(Intralesional injection)
Other
5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared
干预措施: Biopsy (Procedure)
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
Jong Hoon Kim, MD, PhD
Associate Professor
Gangnam Severance Hospital
研究点 (1)
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