UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053516 |
|---|---|
| Receipt number | R000061077 |
| Scientific Title | Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patient |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/02/01 17:54:41 |
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Basic information
Public title
Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patient
Acronym
Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patient
Scientific Title
Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patient
Scientific Title:Acronym
Long-term follow-up study of the efficacy of fosravuconazole in the treatment of onychomycosis in elderly patient
Region
| Japan |
Condition
Condition
onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, we continued the follow-up and investigated the efficacy of re-administration of fosravuconazole in patients with recurrent onychomycosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Patient characteristics: Sex, age, and presence or absence of diabetes/renal failure (on dialysis treatment)/use of immunosuppressive drugs.
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients aged 65 years or older who visited our dermatology outpatient clinic from November 2018 to March 2021, those who were diagnosed with onychomycosis by KOH-based direct microscopy and requested oral treatment were included in the study. Fosravuconazole was administered orally (100 mg/day) for an initial 12 weeks. One hundred and twenty-five patients judged to have responded to the treatment at 48 weeks after completion of the treatment were followed up for subsequent 144 weeks. Patients who experienced a recurrence at less than 24 weeks during the follow-up period were assigned to the short-term recurrence group, and those who experienced a recurrence at 24 weeks or later were assigned to the long-term recurrence group. Fosravuconazole was re-administered and the efficacy was evaluated in each group.
Key exclusion criteria
Patients with hepatic impairment (AST or ALT: 2.5 times the upper reference limit or 100 U/L) and patients having been treated with warfarin were excluded from this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | AYAKA |
| Middle name | |
| Last name | OKUBO |
Organization
Muroran City General Hospital
Division name
Department of Dermatology
Zip code
051-8512
Address
3-8-1 Yamate-cho, Muroran-shi, Hokkaido 051-8512, Japan.
TEL
09050762413
m59_anomura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | AYAKA |
| Middle name | |
| Last name | OKUBO |
Organization
Muroran City General Hospital
Division name
Department of Dermatology
Zip code
0510012
Address
3-8-1 Yamate-cho, Muroran-shi, Hokkaido 051-8512, Japan.
TEL
09050762413
Homepage URL
murohosp191@kujiran.jp
Sponsor or person
Institute
Muroran City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Muroran City General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Muroran City General Hospital
Address
3-8-1 Yamate-cho, Muroran-shi, Hokkaido 051-8512, Japan.
Tel
0143253111
murohosp191@kujiran.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | 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
200
Results
The results suggest that the re-administration of fosravuconazole is safe and as effective as the first administration for elderly patients with recurrent onychomycosis.
Results date posted
| 2024 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061077
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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