UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of CLENAFIN
Acronym	Clinical research of CLENAFIN
Scientific Title	Clinical research of CLENAFIN
Scientific Title:Acronym	Clinical research of CLENAFIN
Region	Japan

Condition
Condition	Trichophytosis unguium
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the following which were not evaluated in the clinical trial of CLENAFIN and to provide the necessary information in clinical practice. 1) the efficacy of administered CLENAFIN in the treatment of trichophytosis unguium patients which have great toenails being clinically affected more than 50% of the tonail area. 2) the efficacy of more than 48 weeks of administered CLENAFIN. by evaluating the efficacy of up to 72 weeks of topically administered CLENAFIN in the treatment of trichophytosis unguium patients which have great toenails being clinically affected 20% and over of the tonail area.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of Clinical efficacy rate, defined as 10% or less affected target nail area
Key secondary outcomes	1) Time course of Clinical Cure rate, defined as zero% involvement of the target nail in addition to Mycologic Cure, defined as negative KOH examination 2) Time course of increasing ratio in health (unaffected) area rate of the target nail 3) Time course of Mycologic Cure rate, difined as negative KOH examination of the target nail 4) Change of QOL score 5) Changes over time in the decrease rate of clinical involvement 6) Changes over time in the clinical involvement

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CLENAFIN is to be applied once daily until Clinical Cure(up to 72 weeks)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1, Verbal and written informed consent obtained from the patient. 2. Male or female, 20 years or older 3. Has a positive KOH examination at the site from the target nail. 4. Clinically diagnosed trichophytosis unguium of at least one great toenail (the "target nail") and 20% and over of target nail area have clinically affected as determined by investigator. 5. Target nail has evidence of nail growth, per patient's report that monthly clipping is needed.
Key exclusion criteria	1. Clinically diagnosed Proximal Subungual Onychomycosis (PSO) or Total Dystrophic Onychomycosis (TDO). 2. Presence of any nail abnormalities without trichophytosis unguium (e.g. nail psoriasis, lichen planus affecting nails, traumatic onychodystrophy) as determined by the investigator. 3. Treatment with CLENAFIN, oral antifungal drugs or antifungal agent for external use within 3 months prior to informed consent. 4. Plannning to receive the following treatment during the study period: (1) oral antifungal drug (2) antifungal agent for external use without CLENAFIN. (3) laser radiation (4) occlusive dressing technique (e.g. urea ointment) 5. Has a negative fungal culture at the central mycology lab. (confirmed by investigator after the subjects' informed consent)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuyuki Kodera
Organization	KAKEN PHARMACEUTICAL CO., LTD.
Division name	Clinical Development Depertment
Zip code
Address	28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-5977-5111
Email	kodera_nobuyuki@kaken.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Morifuji
Organization	RPM Co., Ltd.
Division name	Clinical Development division
Zip code
Address	3-2-4, Nishi-shinjuku,Shinjuku-ku,Tokyo, Japan
TEL	03-5325-5821
Homepage URL
Email	clenafin-cr1@rpmedical.co.jp

Sponsor
Institute	KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization	KAKEN 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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 17 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	223
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	2016 Year 09 Month 30 Day
Date of IRB	2016 Year 10 Month 27 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date	2018 Year 12 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2019 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027939