UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048054 |
|---|---|
| Receipt number | R000054769 |
| Scientific Title | In real-world clinical practice current status of refractory with topical antifungal drug therapy on onychomycosis and efficacy and safety of fosravuconazole switching treatment: a retrospective study |
| Date of disclosure of the study information | 2022/06/14 |
| Last modified on | 2024/07/05 14:14:52 |
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Basic information
Public title
In real-world clinical practice current status of refractory with topical antifungal drug therapy on onychomycosis and efficacy and safety of fosravuconazole switching treatment: a retrospective study
Acronym
In real-world clinical practice current status of refractory with topical antifungal drug therapy on onychomycosis and efficacy and safety of fosravuconazole switching treatment: a retrospective study
Scientific Title
In real-world clinical practice current status of refractory with topical antifungal drug therapy on onychomycosis and efficacy and safety of fosravuconazole switching treatment: a retrospective study
Scientific Title:Acronym
In real-world clinical practice current status of refractory with topical antifungal drug therapy on onychomycosis and efficacy and safety of fosravuconazole switching treatment: a retrospective study
Region
| Japan |
Condition
Condition
Onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the current status and evaluate efficacy and safety of fosravuconazole retrospectively in patients with onychomycosis refractory to topical antifungal drugs in real-world clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical cure rate at the final data of fosravuconazole treatment
Key secondary outcomes
1) Efficacy assessment at the final data of fosravuconazole treatment
2) Change in clinical cure rate from fosravuconazole initiation to 12, 24, 36, and 48 weeks of treatment and at the final data
3) Days to clinical cure
4) Change in nail involvement ratio from fosravuconazole initiation to 12, 24, 36, and 48 weeks of treatment and at the final data
5) Percentage decrease in involvement ratio from fosravuconazole initiation to 12, 24, 36, and 48 weeks of treatment and at the final data
6) Efficacy assessment of fosravuconazole at 12, 24, 36, and 48 weeks and at the final data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with tinea onychomycosis on either toenail of toe I to toe III at the time of initiation of fosravuconazole therapy
2) Patients who started fosravuconazole treatment between July 28, 2018 and February 28, 2021 after switching from a topical nail antifungal agent
Key exclusion criteria
1) Patients with significant thickening, deformation, or discoloration of the nails due to diseases such as palmoplantar pustulosis psoriasis vulgaris, lichen planus, pachyonychia , subungual tumor, or onychogryphosis
2) Patients who refuse to provide medical information for this study
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Minami |
Organization
Minami Surgery Urology
Division name
Dermatology
Zip code
131-0032
Address
5-38-14 Higashimukojima, Sumida-ku, Tokyo, 131-0032
TEL
03-3614-2511
ken0912@me.com
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Tani |
Organization
Nouvelle Place Inc.
Division name
Data management group
Zip code
105-0001
Address
Toranomon 33 Mori Building 10F, 3-8-21 Toranomon, Minato-ku, Tokyo, 105-0001
TEL
03-6680-2525
Homepage URL
data_QC@n-place.co.jp
Sponsor or person
Institute
Sato Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Sato Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Noguchi Dermatology Clinic Ethics Committee
Address
964-1, Uejima, Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3106
Tel
096-237-4112
derma@nogcli.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
南外科泌尿器科（東京都）/Minami Surgery Urology
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jocd/40/5/40_645/_article/-char/ja
Number of participants that the trial has enrolled
71
Results
The clinical cure rate at the final evaluation of fosravuconazole treatment was 42.6% in the FAS. The changes in those rates over time were as follows: 0.0% at baseline and week 12, 2.8% at week 24, 21.1% at week 36, and 62.5% at week 48.
Results date posted
| 2024 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants in the FAS included 24 men (51.1%) and 23 women (48.9%), with an age of 70.6 (SD: 12.3) years.
Participant flow
Registration: 71
Safety: 52
FAS: 47
Adverse events
Fever: 1
High AST: 2
High ALT: 2
High gamma-GTP: 2
High ALP: 1
Outcome measures
Primary endpoint
Clinical cure rate at the final evaluation of fosravuconazole treatment
Secondary endpoint
Reduction rate of opacity ratio after administration of fosravuconazole
Clinical cure rate after administration of fosravuconazole
Number of days until clinical cure
Efficacy evaluation after administration of fosravuconazole
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Study design
Single arm, exploratory, retrospective observational study
2.Study subjects
Patients with onychomycosis who met the eligibility criteria for this study
3.Collection items
Patient background
Gender, age, nail involvement ratio, disease type (DLSO, SWO, PSO, TDO, EO, wedge type, mixed type), severity, number of lesions, presence and location of tinea complications, presence of complications (diabetes), presence of dialysis, number of concomitant oral medications, percentage of medical expense co-payment
Treatment details
Fosravuconazole prescription details, antifungal oral and topical medications indicated for onychomycosis (drug name, date administration started)
Exploratory endpoints
Date of visit, presence or absence of clinical cure, presence or absence of mycological cure (direct microscopy), nail involvement ratio
Laboratory values
Liver function (AST, ALT, gamma-GTP, ALP), renal function (urea nitrogen, creatinine, eGFR)
Adverse events
Event name, date of onset, outcome (recovered, mildly recovered, not recovered, sequelae, death, unknown), date of confirmation of outcome, severity and causal relationship, status of fosravuconazole administration (continued, discontinued, terminated), details of response to adverse event
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054769
