UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium.
Acronym	Clinical research evaluating efficiency of trichophyton antigen kit in tinea unguium.
Scientific Title	Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium.
Scientific Title:Acronym	Clinical research evaluating efficiency of trichophyton antigen kit in tinea unguium.
Region	Japan

Condition
Condition	Tinea Unguium
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficiency of detection for antigen of tinea by trichophyton antigen kit in Tinea unguium.
Basic objectives2	Others
Basic objectives -Others	Performance evaluation of a diagnostic test
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Concordance and discordance rates between the detection results of antigen of tinea by trichophyton antigen kit and the diagnosis of tinea unguium by KOH direct microscopy.
Key secondary outcomes

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	Patients enrolled in the study must meet the following 1)2)3)and 5)or 1)2)4)and 5). 1)Patients aged at least 20 years at the time of enrolment. 2)Patients who have understood the purpose of the study and provided written informed consent for participation in this study. 3)Patients who diagnosed as tinea unguium by KOH direct microscopy. The disease types are all types(DLSO,SWO,PSO,TDO). Specifically, positive is defined as the presence of fungal elements discovered by KOH direct microscopy at a magnification of 100 times. "Weakly positive(+)" is the case that single dermatophyte is discovered in multiple field, and "strongly positive(++)"is the case that multiple dermatophyte are discovered in multiple field. 4)Patients who diagnosed as non tines unguium by KOH direct microscopy for other diseases in the nail area(for example malformed nail). 5)Patients who has residual samples which is collected at the time of KOH direct microscopy at usual clinical care.
Key exclusion criteria	Patients who meet any of the following criteria will be excluded from the study. 1)Patients who has received oral antifungal drugs within 6 months(180 days) or patient who has received antifungal agent for external use within a month(30 days) prior to the enrolment. 2)Patients who participates in other clinical studies(except for observational study). 3)Patients determined to be inappropriate to be enrolled in this study by investigators.
Target sample size	168

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Sawada
Organization	Maruho Co., Ltd.
Division name	Diagnostics Department
Zip code	531-0071
Address	11th floor, Nakatsu Center Building, 1-11-1, Nakatsu, Kita-ku, Osaka, 531-0071, Japan
TEL	06-6371-8005
Email	sawada_apg@mii.maruho.co.jp

Public contact
Name of contact person	1st name Fuminobu Middle name Last name Tomonari
Organization	Linical Co., Ltd.
Division name	Contract Medical Affairs Unit, Clinical Trail Operations
Zip code	105-0021
Address	18th floor, Shiodome Sumitomo Building, 1-9-2, Higashi-shimbashi, Minato-ku, Tokyo, 105-0021, Japan
TEL	03-6215-8005
Homepage URL
Email	tomonari-fuminobu@linical.co.jp

Sponsor
Institute	Maruho Co., Ltd.
Institute
Department

Funding Source
Organization	Maruho Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	JNC CORPORATION Linical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NA
Address	NA
Tel	NA
Email	NA

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	飯田橋皮膚科スキンクリニック（東京都） 医療法人社団 いとう皮ふ科（東京都） 神奈川はた皮膚科クリニック（神奈川県） すずき皮膚科（東京都） 仲皮フ科クリニック（埼玉県） はまぐち皮フ科（東京都） まるやま皮膚科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 10 Month 16 Day
Date of IRB	2019 Year 10 Month 29 Day
Anticipated trial start date	2019 Year 11 Month 06 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry	2020 Year 06 Month 30 Day
Date trial data considered complete	2020 Year 06 Month 30 Day
Date analysis concluded	2020 Year 08 Month 31 Day

Other
Other related information	To evaluate efficiency of detection for antigen of tinea by trichophyton antigen kit in Tinea unguium.

Management information
Registered date	2019 Year 11 Month 18 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044008