UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031817
Receipt No. R000036155
Scientific Title The exploratory study on usability of topical antifungal drugs.
Date of disclosure of the study information 2018/03/28
Last modified on 2018/05/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.