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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |