UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051920 |
|---|---|
| Receipt number | R000059158 |
| Scientific Title | Epidemiological Survey to Assess the Prevalence of Tinea Pedis and Tinea Nails in Japan (Foot Check 2023) |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/12/20 08:15:33 |
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Basic information
Public title
Epidemiological Survey to Assess the Prevalence of Tinea Pedis and Tinea Nails in Japan (Foot Check 2023)
Acronym
Epidemiological Survey to Assess the Prevalence of Tinea Pedis and Tinea Nails
Scientific Title
Epidemiological Survey to Assess the Prevalence of Tinea Pedis and Tinea Nails in Japan (Foot Check 2023)
Scientific Title:Acronym
Epidemiological Survey to Assess the Prevalence of Tinea Pedis and Tinea Nails
Region
| Japan |
Condition
Condition
Tinea Pedis, Tinea Nails
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the potential incidence of tinea pedis and tinea pedis in Japan.
Basic objectives2
Others
Basic objectives -Others
Conduct epidemiological studies on foot and toe nail diseases other than dermatomycosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
prevalence rate of tinea pedis and tinea pedis.
Key secondary outcomes
･Frequency of each disease/symptom and stratified analysis by age and sex
･Percentage of methods for definitive diagnosis of tinea pedis and tinea pedis
･Details and frequency of each treatment for tinea pedis and tinea pedis
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited a research collaborating medical institution during a specific period of time defined by each research collaborating institution during the study period and met all of the selection criteria
(1) Those who visited the research collaborating medical institution (regardless of whether it was the first visit or a retrial, the reason for the visit, or the disease)
(2) Those who have given their consent to cooperate in this research of their own free will after the content of this research has been explained to them.
Key exclusion criteria
Research subjects will be offered the opportunity to refuse the use of their data by opting out.
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Hata |
Organization
Kanagawa-Hata Dermatology Clinic
Division name
Director
Zip code
221-0822
Address
1-20-5 Nishi-Kanagawa, Kanagawa-ku, Yokohama-shi, Kanagawa
TEL
045-435-1112
hiramatsu@npo-hifu-net
Public contact
Name of contact person
| 1st name | YASUNARI |
| Middle name | |
| Last name | HIRAMATSU |
Organization
EBC&M LLC
Division name
Clinical Business Development Department
Zip code
105-0011
Address
2-9-1, Shibakouen, Minato-ku, Tokyo
TEL
+81449544604
Homepage URL
yasunari_hiramatsu@ebc-m.com
Sponsor or person
Institute
Japan Organization of Clinical Dermatologists
Institute
Department
Personal name
Taoashi Eto
Funding Source
Organization
Kaken Pharmaceuticals CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japane
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Health Institute Research of Skin
Address
1-8-9 Uchikanda, Chiyoda-ku, Tokyo
Tel
1-8-9 Uchikanda, Chiyoda-ku, Tokyo
info@npo-hifu.net
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
日本臨床皮膚科医会会員施設
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
https://plaza.umin.ac.jp/~jocd/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jocd/41/1/41_66/_article/-char/ja
Number of participants that the trial has enrolled
14588
Results
he potential incidence of tinea pedis and tinea cruris in Japan was estimated at 13.7% (18.9% in men and 9.6% in women) and 7.9% (10.6% in men and 5.8% in women) for tinea pedis, and 16.6% (22.3% in men and 12.2% in women) for potential patients affected with either tinea pedis or tinea cruris.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 05 | Day |
Baseline Characteristics
A questionnaire survey on "Foot Health Check (Foot Check 2023)" was conducted among patients who visited the dermatology departments of 211 member institutions of the Japan Society of Clinical Dermatologists nationwide between April 2023 and May 2023. Out of 23,087 patients who responded to the survey, 2,116 patients who visited for "examination of athlete's foot or onychomycosis" were excluded. Among the 14,588 patients who agreed to participate in the Foot Health Check, doctors actually checked the presence or absence of diseases and symptoms of the patients' feet and nails, and made a definitive diagnosis of tinea pedis or onychomycosis when suspected.
Participant flow
A questionnaire survey on "Foot Health Check (Foot Check 2023)" was conducted among patients who visited the dermatology departments of 211 member institutions of the Japan Society of Clinical Dermatologists nationwide between April 2023 and May 2023. Out of 23,087 patients who responded to the survey, 2,116 patients who visited for "examination of athlete's foot or onychomycosis" were excluded. Among the 14,588 patients who agreed to participate in the Foot Health Check, doctors actually checked the presence or absence of diseases and symptoms of the patients' feet and nails, and made a definitive diagnosis of tinea pedis or onychomycosis when suspected.
Adverse events
non
Outcome measures
Frequency of onychomycosis and tinea pedis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 20 | Day |
Other
Other related information
In April and May, the cooperating medical institutions will confirm the wishes of patients who visit them for a foot health check (foot check) in addition to their regular medical care, and conduct foot checks for those who wish to have one.
Management information
Registered date
| 2023 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059158
