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临床试验/JPRN-UMIN000025907
JPRN-UMIN000025907已完成未知

Clinical research evaluating utility of detection for pathogen of trichophytosis unguium by DERMAQUICK - Evaluating utility of detection for trichophytosis unguium by novel detection kit

Hayashibe Dermatology Clinic0 个研究点目标入组 120 人开始时间: 2017年2月6日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
120

研究概览

简要总结

A physician-led clinical study was conducted to investigate the utility of tinea antigen detection kit (DERMA-Quick Nail tinea), available for diagnosis of tinea unguium. We compared the results of microscopic inspection and those of investigated test kit. Both were performed on each of 126 enrolled patients who were either suspected of tinea unguium or who were recommended for differential diagnosis from tinea unguium. The concordance rate of the two tests, the primary endpoint, was 88.9 %, showing sufficient clinical utility of the test kit. Participating dermatologists evaluated positively the convenience of the investigated kit and many regarded the test kit of being feasible and useful in actual clinical settings. As the use of topical antifungal agents have become more generally prevalent, greater accuracy in the diagnosis of nail tinea is called for. The investigated test kit seems to be able to be a supplement to microscopic inspection to improve the accuracy of the diagnosis, reducing patient burden, and yielding potential health economic benefits.

研究设计

研究类型
Observational

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. 1)Patient who has used Oral antifungal drugs within 6 months 2)Patient who has used antifungal agent for external use within a month prior to enrolling in this study 3)Patient who has difficulty to get informed consent. 4)Patient recognized by investigator as inappropriate for this study

研究者

发起方
Hayashibe Dermatology Clinic

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