UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research evaluating utility of detection for pathogen of trichophytosis unguium by DERMAQUICK
Title of the study (Brief title)	Evaluating utility of detection for trichophytosis unguium by novel detection kit
Region	Japan

Condition
Condition	trichophytosis unguium
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficiency test of external diagnostic medicine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	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
Key secondary outcomes	Convenience of detection

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient who have Suspition of trichophytosis unguium 2) Patient must be at least 20 years of age. Irrespective of sex
Key exclusion criteria	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
Target sample size	120

Research contact person
Name of lead principal investigator	Kazuhito Hayashibe
Organization	Hayashibe Dermatology Clinic
Division name	Dermatology
Address	ELM Plaza 305, 2-3-1 Suzukakedai, Sanda, Hyogo, Japan 669-1322
TEL	079-565-8808
Email	hayashibe@ikkeikai.org

Public contact
Name of contact person	Kazuhito Hayashibe
Organization	Hayashibe Dermatology Clinic
Division name	Dermatology
Address	ELM plaza 305, 2-3-1 Suzukakedai, Sanda, Hyogo, Japan 669-1322
TEL	079-565-8808
Homepage URL
Email	hayashibe@ikkeikai.org

Sponsor
Institute	Hayashibe Dermatology Clinic
Institute
Department

Funding Source
Organization	Self Funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hyogo association of Dermatologist
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人　社団　一恵会 はやしべ皮フ科

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 28 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2017 Year 03 Month 15 Day
Date of closure to data entry	2017 Year 03 Month 25 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	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.
Other related information	none

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029780