UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036339 |
|---|---|
| Receipt number | 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 | 2020/02/12 12:46:53 |
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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
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
hayase.atsuko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041405
