UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001949 |
|---|---|
| Receipt number | R000002374 |
| Scientific Title | A study on measurement of KP-103 concentration in nails (Phase I) - Investigation of KP-103 concentration in nails following repeated topical application to toenails in patients with onychomycosis - |
| Date of disclosure of the study information | 2009/05/08 |
| Last modified on | 2009/11/20 17:16:30 |
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Basic information
Public title
A study on measurement of KP-103 concentration in nails (Phase I)
- Investigation of KP-103 concentration in nails following repeated topical application to toenails in patients with onychomycosis -
Acronym
A study on measurement of KP-103 concentration in nails (Phase I)
Scientific Title
A study on measurement of KP-103 concentration in nails (Phase I)
- Investigation of KP-103 concentration in nails following repeated topical application to toenails in patients with onychomycosis -
Scientific Title:Acronym
A study on measurement of KP-103 concentration in nails (Phase I)
Region
| Japan |
Condition
Condition
Onychomycosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate KP-103 concentrations in the affected versus normal toenails as well as the first versus second toenail with different nail thickness following repeated topical application of KP-103 5% or 10% to all toenails for 28 days in patients with onychomycosis. Furthermore to investigate safety when applied to all toenails.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KP-103 concentration in nails, onset of adverse effects and their severity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once daily before bedtime KP-103 5% is applied each 2 drops to left and right first toenails and each one drop to all other toenails for 28 days.
Interventions/Control_2
Once daily before bedtime KP-103 10% is applied each 2 drops to left and right first toenails and each one drop to all other toenails for 28 days.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patient with onychomycosis in either left or right first toenail or both, as demonstrated by mycological examination (direct KOH microscopy) and clinical symptoms
(2) With or without left or right second toenail affected with onychomycosis
(3) All types and severity of onychomycosis
(4) Patient who can personally provide written informed consent
Key exclusion criteria
(1) Patient on corticosteroid (except external preparation for topical action to areas other than toenails is allowable)
(2) Patient with problems in safety
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Watanabe |
Organization
Graduated school of Medicine, Teikyo University
Division name
Department of dermatology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KAKEN PHARMACEUTICAL CO.,LTD.
Division name
Clinical Development Department
Zip code
Address
2-28-8, Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
KAKEN PHARMACEUTICAL CO.,LTD.
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 08 | 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
| 2009 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 08 | Day |
Last modified on
| 2009 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002374
