UMIN-CTR Clinical Trial

Basic information
Public title	A study on noninvasive in vivo analysis of human skin
Acronym	A study on noninvasive in vivo analysis of human skin
Scientific Title	A study on noninvasive in vivo analysis of human skin
Scientific Title:Acronym	A study on noninvasive in vivo analysis of human skin
Region	Japan

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

Objectives
Narrative objectives1	To confirm the relationship between noninvasive in vivo analysis and dermatological conditions for healthy female skin
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of wrinkle formation, skin water content, transepidermal water loss, skin elasticity and OCT.
Key secondary outcomes

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 in constant temperature and humidity room.
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	75 years-old >=
Gender	Female
Key inclusion criteria	Healthy Japanese females
Key exclusion criteria	-Subjects with sensitive skin or allergy against facial cleanser or cosmetic products -Subjects with skin diseases such as atopic dermatitis, psoriasis and severe acne -Subjects with pollen allergy -Subjects seemed inappropriate to participate in this study by the principle investigator -Subjects who have medical treatment or take some medicine for their facial skin
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuya Sayou
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	3-28, 5-chome, Kotobuki-cho, Odawara, Kanagawa, 250-0002, JAPAN
TEL	+81-465-34-6116
Email	sayou.tetsuya@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kohei Yamazaki
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	3-28, 5-chome, Kotobuki-cho, Odawara, Kanagawa, 250-0002, JAPAN
TEL	+81-465-34-6116
Homepage URL
Email	yamazaki.kouhei@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	University of Tsukuba
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	H29-A023
Org. issuing International ID_1	701 Research, Inc
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社セブンオーワンリサーチ Above Access（東京） 国立大学法人筑波大学（茨城）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 26 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	2017 Year 05 Month 18 Day
Date of IRB	2017 Year 05 Month 18 Day
Anticipated trial start date	2017 Year 06 Month 06 Day
Last follow-up date	2021 Year 05 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2021 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031455