UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study of noninvasive aging index of epidermis.
Title of the study (Brief title)	An exploratory study of noninvasive aging index of epidermis.
Region	Japan

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

Objectives
Narrative objectives1	To establish noninvasive aging index of epidermis.
Basic objectives2	Others
Basic objectives -Others	To establish noninvasive aging index of epidermis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Relation between the properties of the auto-fluorescence emitted from epidermis with age - Relation between the optical properties (scattering, absorbance) of skin with age - Relation between the morphological characteristic of skin surface with age - Relation between the trace component on skin surface with age.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Measure the noninvasive aging indexes of epidermis to 20's age volunteers.
Interventions/Control_2	Measure the noninvasive aging indexes of epidermis to 60's age volunteers.
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	69 years-old >=
Gender	Female
Key inclusion criteria	-Healthy female in 20's and 60's age groups.
Key exclusion criteria	-Subjects with cutaneous symptoms of atopic dermatitis -Subjects regularly going to hospital for sickness and/or who are taking OTC or prescription medicine -Subjects undergoing hormone therapy -Subjects with smoking habit -Subjects with clinically-significant disorder (eczema, a scratch etc.) at the sites to be studied - Subjects with excess sunburn at the test site - Subjects who are pregnant or had a baby within one year. -Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Keiichi Sugata
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7872
Homepage URL
Email	sugata.keiichi@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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 11 Month 29 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

Management information
Registered date	2016 Year 11 Month 28 Day
Last modified on	2017 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028784