UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015368
Receipt number R000017885
Scientific Title Evaluation of dermato-pharmacokinetics after single application of lanoconazole
Date of disclosure of the study information 2014/10/10
Last modified on 2015/02/06 21:10:51

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Basic information

Public title

Evaluation of dermato-pharmacokinetics after single application of lanoconazole

Acronym

Evaluation of dermato-pharmacokinetics after single application of lanoconazole

Scientific Title

Evaluation of dermato-pharmacokinetics after single application of lanoconazole

Scientific Title:Acronym

Evaluation of dermato-pharmacokinetics after 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 external medication in human dermis

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pharmacokinetics parameter

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

application of lanoconazole external medication

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: >=18.5, <28.0

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 Hospital

Division name

Clinical Pharmacology Center

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 Hospital

Division name

Clinical Pharmacology Center

Zip code


Address

1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN

TEL

097-586-5952

Homepage URL


Email

imaih@oita-u.ac.jp


Sponsor or person

Institute

Dept of Clinical Pharmacology & Therapeutics, Oita University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Dept of Clinical Pharmacology & Therapeutics, Oita University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2014 Year 10 Month 10 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

2014 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 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

2014 Year 10 Month 08 Day

Last modified on

2015 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017885


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name