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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019856
Receipt No. R000022937
Scientific Title Evaluation of dermato-pharmacokinetics after repeated application of lanoconazole -whole day application 5days repeated trial-
Date of disclosure of the study information 2015/11/20
Last modified on 2016/11/21

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Basic information
Public title Evaluation of dermato-pharmacokinetics after repeated application of lanoconazole -whole day application 5days repeated trial-
Acronym Evaluation of dermato-pharmacokinetics after repeated application of lanoconazole
Scientific Title Evaluation of dermato-pharmacokinetics after repeated application of lanoconazole -whole day application 5days repeated trial-
Scientific Title:Acronym Evaluation of dermato-pharmacokinetics after repeated application of lanoconazole
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the pharmacokinetics of lanoconazole external medication in human dermis
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes pharmacokinetic parameters of lanoconazole in stratum corneum
(time of assessment: within 3 months after completion of drug administration)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 external administration of lanoconazole cream
dose: 350mg on the 1st day with gradual decrease
five days repeated administration
Interventions/Control_2
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
45 years-old >
Gender Male
Key inclusion criteria BMI >=17.5, <30.0
Key exclusion criteria *any skin abnormality
*any drug, cosmetics, or food allergy
*any abnormal findings in the following items,
hematology, biochemistry, urinalysis, blood pressure, ECG, and clinical examination
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Imai
Organization Oita university Faculty of medicine
Division name Dept of clinical pharmacology and therapeutics
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Email imaih@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Imai
Organization Oita university Faculty of medicine
Division name Dept of clinical pharmacology and therapeutics
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Homepage URL
Email imaih@oita-u.ac.jp

Sponsor
Institute Dept of Clinical Pharmacology & Therapeutics, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Maruho pharmaceutical company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2015 Year 11 Month 20 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
2015 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 10 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
2015 Year 11 Month 19 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022937

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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