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
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
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
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
