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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025907
Receipt No. R000029780
Scientific Title Clinical research evaluating utility of detection for pathogen of trichophytosis unguium by DERMAQUICK
Date of disclosure of the study information 2017/02/06
Last modified on 2017/08/01

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Basic information
Public title Clinical research evaluating utility of
detection for pathogen of trichophytosis
unguium by DERMAQUICK
Acronym Evaluating utility of detection for
trichophytosis unguium by novel detection kit
Scientific Title Clinical research evaluating utility of
detection for pathogen of trichophytosis
unguium by DERMAQUICK
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhito Hayashibe
Organization Hayashibe Dermatology Clinic
Division name Dermatology
Zip code
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
1st name
Middle name
Last name Kazuhito Hayashibe
Organization Hayashibe Dermatology Clinic
Division name Dermatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
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.
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
2017 Year 01 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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