UMIN-CTR Clinical Trial

Basic information
Public title	Dermato-pharmacokinetic study of single application of lanoconazole
Acronym	Dermato-pharmacokinetic study of single application of lanoconazole
Scientific Title	Dermato-pharmacokinetic study of single application of lanoconazole
Scientific Title:Acronym	Dermato-pharmacokinetic study of single 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 in human dermis after single application
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
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	6

Research contact person
Name of lead principal investigator	1st name Hiromitsu Middle name Last name Imai
Organization	Oita University Faculty of Medicine
Division name	Dept of Medical Ethics
Zip code	8795593
Address	1-1 Idaigaoka, Hasama, Yufu, Oita, JAPAN
TEL	097-586-5952
Email	imaih@oita-u.ac.jp

Public contact
Name of contact person	1st name Hiromitsu Middle name Last name Imai
Organization	Oita University Faculty of Medicine
Division name	Dept of Medical Ethics
Zip code	8795593
Address	1-1 Idaigaoka, Hasama, Yufu, Oita, JAPAN
TEL	097-586-5952
Homepage URL
Email	imaih@oita-u.ac.jp

Sponsor
Institute	Oita University
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	Institutional Review Board, Oita University Hospital
Address	1-1 Idaigaoka, Hasama, Yufu, Oita, JAPAN
Tel	097-586-6163
Email	gcrcjimu@oita-u.ac.jp

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	2017 Year 10 Month 01 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	2017 Year 08 Month 21 Day
Date of IRB	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 10 Month 02 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 22 Day
Last modified on	2020 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033425