UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029240 |
|---|---|
| Receipt number | R000033425 |
| Scientific Title | Dermato-pharmacokinetic study of single application of lanoconazole |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/03/25 15:19:35 |
* 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
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
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
imaih@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033425
