UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the age-related changes of the skin
Title of the study (Brief title)	A study of the age-related changes of the skin
Region	Japan

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

Objectives
Narrative objectives1	To confirm the factors of age-related changes of the skin
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. the measured values by instruments after acclimatization for 20 min; water content, the transepidermal water loss, the skin viscoelasticity, the skin color, the area of stratum corneum, the status of wrinkle and texture, the sebum content, the blood flow, the skin and body temperature, the skin pH and the skin transparency) 2. the results of questionnaires
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	measurement and questionnaire listed in major outcome for 2hr.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	32 years-old <=
Age-upper limit	58 years-old >=
Gender	Female
Key inclusion criteria	Healthy subjects
Key exclusion criteria	A person who participates another Clinical trial
Target sample size	150

Research contact person
Name of lead principal investigator	Yoshinori Sugiyama
Organization	Kao Corporation
Division name	Health Beauty Products Research
Address	5-3-28, Kotobuki-cho, Odawara, Kanagawa, Japan
TEL	0465-35-3175
Email	sugiyama.yoshinori@kao.co.jp

Public contact
Name of contact person	Noriaki Nakagawa
Organization	Kao Corporation
Division name	Health Beauty Products Research
Address	5-3-28, Kotobuki-cho, Odawara, Kanagawa, Japan
TEL	0465-35-3175
Homepage URL
Email	nakagawa.noriaki@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Self funding
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	花王株式会社小田原事業場（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
Anticipated trial start date	2016 Year 04 Month 02 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	-Design and Setting Observation Study of skin physical properties -Recruiting Recruiting females in Tokyo metropolitan area.

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2016 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024600