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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036339
Receipt No. R000041405
Scientific Title A study on the diurnal and day variation of biological barrier
Date of disclosure of the study information 2019/03/29
Last modified on 2019/04/26

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Basic information
Public title A study on the diurnal and day variation of biological barrier
Acronym A study on the diurnal and day variation of biological barrier
Scientific Title A study on the diurnal and day variation of biological barrier
Scientific Title:Acronym A study on the diurnal and day variation of biological barrier
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is two; to understand the diurnal and day variation range of biological barrier, and to clarify the relationship among individual differences of biological barrier considering intraday and day variation.
Basic objectives2 Others
Basic objectives -Others The aim of this study is two; to understand the diurnal and day variation range of biological barrier, and to clarify the relationship among individual differences of biological barrier considering intraday and day variation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indicators of biological barrier;
ex) body temperature, antiviral activity
Key secondary outcomes Properties related to biological barrier (temperature, pH, lactic acid content)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
59 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria Subjects suffering from serious diseases (liver disorder, renal disorder, myocardial infarction, etc.)
Subjects visiting hospital or taking internal or external medicine (including marketing medicine) on a daily basis for treatment purposes
Subjects who get symptoms such as itching or reddening when alcohol is applied to the skin.
Others who judged that they are inappropriate by the research officer and the staff
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Mori
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7769
Email mori.takuya@kao.com

Public contact
Name of contact person
1st name Atsuko
Middle name
Last name Hayase
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7613
Homepage URL
Email hayase.atsuko@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@kao.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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 29 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 10
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 01 Month 23 Day
Date of IRB
2019 Year 01 Month 23 Day
Anticipated trial start date
2019 Year 02 Month 12 Day
Last follow-up date
2020 Year 01 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is two; to understand the diurnal and day variation range of biological barrier, and to clarify the relationship among individual differences of biological barrier considering intraday and day variation.

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041405

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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