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临床试验/NCT00155532
NCT00155532已完成1 期

Skin Denervation in Systemic Lupus Erythematosus

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Quantitation of epidermal innervation

研究概览

简要总结

To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

详细描述

To address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (SLE) cohort by evaluating the extent of cutaneous innervation. Patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. Skin biopsy with PGP 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. Intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in SLE.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of systemic lupus erythematosus based on the consensus criteria

排除标准

  • Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.

结局指标

主要结局

Quantitation of epidermal innervation

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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Skin Denervation in Systemic Lupus Erythematosus | 临床试验