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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036939
Receipt No. R000042094
Scientific Title Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution)
Date of disclosure of the study information 2019/06/21
Last modified on 2020/08/27

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Basic information
Public title Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution)
Acronym Clinical research about the change factors for amount of drug in stratum corneum
Scientific Title Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution)
Scientific Title:Acronym Clinical research about the change factors for amount of drug in stratum corneum
Region
Japan

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

Objectives
Narrative objectives1 To investigate influential factors on amount of drug in stratum corneum by conducting dermato-pharmacokinetic study under several conditions
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Amount of lanoconazole in stratum corneum in each application time points by 24 hours after drug application
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 Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Topical application of lanoconazole and sampling of stratum corneum by using several methods
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
35 years-old >
Gender Male
Key inclusion criteria (1)20 to 34 years at the time of obtaining informed consent
(2) BMI>=18.5, <25.0
Key exclusion criteria (1)any medical history of illness and allergy to be conceivable that is unsuitable to enroll for the study
(2)any skin abnormality
(3)any abnormal findings in standard Labtest or vital signs
Target sample size 68

Research contact person
Name of lead principal investigator
1st name Kayo
Middle name
Last name Taira
Organization SOUSEIKAI Hakata Clinic
Division name Clinical Pharmacology Department
Zip code 812-0025
Address Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
TEL 092-283-7701
Email kayo-taira@lta-med.com

Public contact
Name of contact person
1st name Akane
Middle name
Last name Yamada
Organization SOUSEIKAI Hakata Clinic
Division name Department of Clinical Operations
Zip code 812-0025
Address Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
TEL 092-283-7701
Homepage URL
Email akane-yamada@lta-med.com

Sponsor
Institute Maruho Co.,LTD.
Institute
Department

Funding Source
Organization Maruho Co.,LTD.
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 Hakata Clinic Institutional Review Board
Address 6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025
Tel 092-283-7701
Email akane-yamada@lta-med.com

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
2019 Year 06 Month 21 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 68
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
2019 Year 04 Month 22 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 06 Month 21 Day
Last follow-up date
2020 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2020 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042094

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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