UMIN-CTR Clinical Trial

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
Email	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
Email	data_QC@n-place.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)

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
Email	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
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Open public recruiting
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	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054769

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.