UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045924 |
|---|---|
| Receipt number | R000052416 |
| Scientific Title | Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2022/11/02 16:50:28 |
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Basic information
Public title
Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study
Acronym
Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study
Scientific Title
Efficacy and safety of fosravuconazole for the treatment of onychomycosis: A multicenter, retrospective study
Scientific Title:Acronym
NAILIN retro
Region
| Japan |
Condition
Condition
Onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of fosravuconazole retrospectively in routine clinical practice for patients with onychomycosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical cure rate at 48 weeks of fosravuconazole administration
Key secondary outcomes
1) Change in clinical cure rate at 12, 24, 36 and 48 weeks of fosravuconazole administration
2) Change in mycological cure rate at 12, 24, 36 and 48 weeks of fosravuconazole administration
3) Days to clinical cure
4) Change in nail involvement ratio at 12, 24, 36 and 48 weeks of fosravuconazole administration
5) Percent decrease in nail involvement ratio at 12, 24, 36 and 48 weeks of fosravuconazole administration
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) Patient 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
500
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Noguchi |
Organization
Noguchi Dermatology Clinic
Division name
Dermatology
Zip code
861-3101
Address
1834-1, namazu, kashimamachi, kamimashikigun, Kumamoto
TEL
096-237-4112
derma@nogcli.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Murabayashi |
Organization
Mebix, Inc.
Division name
Clinical Research Operation
Zip code
107-0052
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-4362-4504
Homepage URL
NLI_retro@mebix.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)
Eisai Co., Ltd.
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, kitamachi, iwaya, nada-ku, kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.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
のぐち皮ふ科 (熊本県)
仲皮フ科クリニック (埼玉県)
比留間医院 (埼玉県)
糀谷皮膚科 (東京都)
松田ひふ科医院 (福岡県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
350
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
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. Study design
A multicenter, exploratory retrospective study
2. Research subject
Patients who started fosravuconazole treatment between June 1st, 2019 and April 30th, 2020
3. Collection items
･Characteristics of subjects
Sex, Age, Nail involvement ratio, Disease type of onychomycosis, Severity of onychomycosis, Number of nails affected by onychomycosis,
Presence/absence and the site of complications of tinea, Type of combined internal medicine, Contents of the treatment to onychomycosis during one month before first fosravuconazole administration
･Contents of the treatment
Contents of fosravuconazole prescription, oral and topical medication for antimycotic indicated for onychomycosis
･Effectiveness outcome measures
Date of hospital visit, Presence/absence of clinical cure, Presence/absence of mycological cure (direct microscopy), Nail involvement ratio
･Clinical laboratory test result
Liver function(AST, ALT, gamma-GTP), Renal function(BUN, Creatinine)
･Adverse events
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052416
