UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory study on usability of topical antifungal drugs.
Acronym	The exploratory study on usability of topical antifungal drugs.
Scientific Title	The exploratory study on usability of topical antifungal drugs.
Scientific Title:Acronym	The exploratory study on usability of topical antifungal drugs.
Region	Japan

Condition
Condition	Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usability of Luconac solution 5% and Clenafin solution 10% in adults.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	VAS of five assessements on the usability.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Luconac solution 5% is applied to all toes. Single dose.
Interventions/Control_2	Clenafin solution 10% is applied to all toes. Single dose.
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	40 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Adult male and female with healthy toes. 2.Those who have not medicated with topical antifungal drugs. 3.Those who have toes without inflammatory and external injury including nail trinea.
Key exclusion criteria	1.Those who have malfunctions on fingers or upper limb that impede the embrocation action. 2.Those who have other diseases that may impede the embrocation action, such as visual handicapped except hypermetropia or neuropathy etc. 3.Those who have diseases that impede the informed concent or the operation of study, such as dementia. 4.Those who are during lactation, pregnancy or possible pregnancy. 5.Those who have history of hypersensitiveness on the study drugs. 6.Others who are deemed inappropriate by the investigator to conduct this study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutoshi Harada
Organization	Tokyo Medical University
Division name	Department of Dermatology
Zip code
Address	Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	kharada@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satoko Shimizu
Organization	Tokyo Research Center of Clinical Pharmacology Co., Ltd.
Division name	Clinical trial promotion II dept.
Zip code
Address	Yotsuya-medical-bldg. 6F, Samoncho 20, Shinjuku-ku, Tokyo
TEL	03-5366-3454
Homepage URL
Email	s-shimizu@trcp.co.jp

Sponsor
Institute	Medical Corporation Shinanokai Samoncho Clinic
Institute
Department

Funding Source
Organization	POLA PHARMA INC.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	医療法人社団　信濃会　左門町クリニック(東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 28 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	Completed
Date of protocol fixation	2018 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036155

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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