UMIN-CTR Clinical Trial

Basic information
Public title	The study to evaluate variations of skin molecules in the day and from day to day.
Acronym	The study to evaluate variations of skin molecules in the day and from day to day.
Scientific Title	The study to evaluate variations of skin molecules in the day and from day to day.
Scientific Title:Acronym	The study to evaluate variations of skin molecules in the day and from day to day.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the variations of skin molecules in the day and from day to day.
Basic objectives2	Others
Basic objectives -Others	To evaluate the regional differences of skin molecules between face and scalp.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The variations of skin molecules in the day and from day to day.
Key secondary outcomes	-The relationship between skin molecules and questionnaires. -The evaluation of regional differences of skin molecules between face and scalp.

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	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy male panelists who are 20-49 years old. 2.Healthy female panelists who are 20-49 years old and have regular menstruation. 3.Panelists who agree to have their typical daily routines.
Key exclusion criteria	1.Panelists who have irregular menstruation or who experience menopause. 2.Panelists who has become pregnant and breast-feeding. In addition, panelists who have possibility of pregnant during the study period. 3.Panelists who have the skin problems on the face, such as atopic dermatitis, psoriasis vulgaris, and acnes. 4.Panelists who have a severe tanning on the face. 5.Panelists who smoke. 6.Panelists who use the drug such as, anti-inflammatory drug, antibiotics, hypnotic, anti- allergic drug, analgesic drug, hormone preparation, laxative, intestinal regulator, and other drugs as routinely. 7.Panelists who attend for treatment of chronic diseases (e.g. stomach, intestine, kidney, heart, blood pressure, skin, and other illness) or have history of attending within a month before participation in this study (Manual therapy, chiropractic, massages, and osteopathic manipulation are exceptional). 8.Panelists who attend cosmetic therapy (e.g. chemical peeling, laser therapy) or have history of cosmetic surgery (e.g. cosmetic orthopedics, collagen injection). 9.Male panelists who randomly shave during the study period. Female panelists who randomly remove downy hairs on their face during the study period. 10.Panelists who have participated or scheduled in other study during the study period. 11.Panelists who is considered as inappropriate in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takayoshi Middle name Last name Inoue
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	070-3297-0982
Email	inoue.takayoshi@kao.com

Public contact
Name of contact person	1st name Yui Middle name Last name Ueda
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	070-3297-0962
Homepage URL
Email	ueda.yui@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	2018 Year 10 Month 19 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	2018 Year 10 Month 18 Day
Date of IRB	2018 Year 10 Month 18 Day
Anticipated trial start date	2018 Year 10 Month 22 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information	To evaluate the regional differences of skin molecules between face and scalp.

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2020 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039415