UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054941 |
|---|---|
| Receipt number | R000062758 |
| Scientific Title | Secondary use study of data from a multicenter, retrospective study on the efficacy and safety of fosravuconazole for the treatment of onychomycosis: A study on the elongation of healthy nails during foslavuconazole treatment |
| Date of disclosure of the study information | 2024/07/11 |
| Last modified on | 2025/12/19 11:03:25 |
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Basic information
Public title
Secondary use study of data from a multicenter, retrospective study on the efficacy and safety of fosravuconazole for the treatment of onychomycosis: A study on the elongation of healthy nails during foslavuconazole treatment
Acronym
Secondary use study of data from a multicenter, retrospective study on the efficacy and safety of fosravuconazole for the treatment of onychomycosis: A study on the elongation of healthy nails during foslavuconazole treatment
Scientific Title
Secondary use study of data from a multicenter, retrospective study on the efficacy and safety of fosravuconazole for the treatment of onychomycosis: A study on the elongation of healthy nails during foslavuconazole treatment
Scientific Title:Acronym
Secondary use study of data from a multicenter, retrospective study on the efficacy and safety of fosravuconazole for the treatment of onychomycosis: A study on the elongation of healthy nails during foslavuconazole treatment
Region
| Japan |
Condition
Condition
Onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the elongation of healthy nails during foslavuconazole treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Elongation of healthy nails during foslavuconazole treatment
Key secondary outcomes
Change over time in nail involvement ratio during foslavuconazole treatment
Exploration for factors affecting healthy nail elongation
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 as onychomycosis on either toenail of toe I to toe III by direct microscopy and/or fungal culture at the time of initiation of fosravuconazole treatment
2) Patients who started fosravuconazole treatment according to the medical package insert between June 1st, 2019 and April 30th, 2020
Key exclusion criteria
1) Patients with significant nail thickening, deformity, or discoloration due to diseases such as palmoplantar pustulosis of the nails, psoriasis vulgaris, lichen planus of the nails, pachyonychia, tumor under the nails, onychogryphosis, etc.
2) Patients who have refused to provide medical information for this study
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Naka |
Organization
Naka Dermatology Clinic
Division name
Dermatology
Zip code
350-1123
Address
13-10 Wakita-honcho, Kawagoe, Saitama
TEL
049-246-0039
w-naka@kb4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Naka |
Organization
Naka Dermatology Clinic
Division name
Dermatology
Zip code
350-1123
Address
13-10 Wakita-honcho, Kawagoe, Saitama
TEL
049-246-0039
Homepage URL
w-naka@kb4.so-net.ne.jp
Sponsor or person
Institute
Naka Dermatology Clinic
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, Japan
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
仲皮フ科クリニック (埼玉県)
のぐち皮ふ科 (熊本県)
比留間医院 (埼玉県)
糀谷皮膚科 (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 11 | 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
108
Results
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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Study design
Secondary use study of data from a multicenter, retrospective study
2.Participants
Patients enrolled in "Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study" (Unique ID issued by UMIN: UMIN000045924)
3.Collection items
See collection items of "Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study" (Unique ID issued by UMIN: UMIN000045924)
4. Others
"Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study" (Unique ID issued by UMIN: UMIN000045924) began enrollment on November 1, 2021 and ended January 31, 2022.
This study used data enrolled during the above period.
Management information
Registered date
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062758
