Clinical research evaluating utility of detection for pathogen of trichophytosis unguium by DERMAQUICK
- Conditions
- trichophytosis unguium
- Registration Number
- JPRN-UMIN000025907
- Lead Sponsor
- Hayashibe Dermatology Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare efficiency of detection for pathogen of trichophytosis unguium to test samples from suspected area as trichophytosis unguium by DERMAQUICK and by direct microscopy
- Secondary Outcome Measures
Name Time Method Convenience of detection
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