UMIN-CTR Clinical Trial

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	2020 Year 02 Month 10 Day

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	2020 Year 02 Month 12 Day

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