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 UMIN000001949
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute KAKEN PHARMACEUTICAL CO.,LTD.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.