UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analyses of the physical properties and the molecules in human healthy skins.
Title of the study (Brief title)	Analyses of the physical properties and the molecules in human healthy skins.
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the physical properties and the molecules in human healthy skins.
Basic objectives2	Others
Basic objectives -Others	The observational study the relationship between skin physical property and molecules.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between sebum content and gene expressions.
Key secondary outcomes	The relationships between sebum content, color, moisture, pH in skin and gene expressions, proteins, concentration of hormones.

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 and Female
Key inclusion criteria	1.Panelists with healthy faces who are 20-59 years old. 2.Panelists who do not have skin troubles and diseases. 3.Panelists who have normal weight (BMI: Between 18.5 and 25.0) 4.Panelists who agree to have their typical daily routines.
Key exclusion criteria	1.Panelists who have some skin troubles and diseases. 2.Panelists who used the antibiotics in the last 2 weeks. 3.Panelists who have undergone some beauty treatments on their faces. 4.Panelists who receive the cares from a doctor or dermatologist for their facial skin issues. 5.Panelists who have started any types of estrogen or hormone therapies. 6.Panelists who smoke. 7.Panelists who are pregnant or breastfeeding. 8.Panelists participating in, or scheduled to participate in, another study during the study period.
Target sample size	80

Research contact person
Name of lead principal investigator	Yoshito Takahashi
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	5-3-28, Kotobuki-machi, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL	0465-34-6116
Email	takahashi.yoshito@kao.co.jp

Public contact
Name of contact person	Takayoshi Inoue
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	inoue.takayoshi@kao.co.jp

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)

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	株式会社インフォワード（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 14 Day
Anticipated trial start date	2016 Year 10 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Panelists will be recruited by Inforward, inc.

Management information
Registered date	2016 Year 11 Month 09 Day
Last modified on	2017 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028498