UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025907
Receipt number 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 15:42:38

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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 or person

Institute

Hayashibe Dermatology Clinic

Institute

Department

Personal name



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

Value
https://center6.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