UMIN-CTR Clinical Trial

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
Email	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
Email	NLI_retro@mebix.co.jp

Sponsor
Institute	Sato Pharmaceutical Co.,Ltd
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052416