UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031817 |
|---|---|
| Receipt number | 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 09:30:44 |
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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
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
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Medical Corporation Shinanokai Samoncho Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
