UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the effect by skincare method based on autogenic training principle.
Acronym	A Study on the effect of the original skincare method
Scientific Title	A Study on the effect by skincare method based on autogenic training principle.
Scientific Title:Acronym	A Study on the effect of the original skincare method
Region	Japan

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

Objectives
Narrative objectives1	To confirm effects by original skincare method based on autogenic training principles
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the stratum corneum water content, the skin color, the skin viscoelasticity, the surface texture, skin temperature recovering after cool treatment, and heart rate variability after the repeated original skincare routine for 8week.
Key secondary outcomes	Analysis of the relationship between the change of the stratum corneum water content, the skin color, the skin viscoelasticity, the surface texture, skin temperature recovering after cool treatment and heart rate variability, and the change of psychological scale.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Original skincare routine (night) is performed for 8weeks
Interventions/Control_2	Skincare routine as subjects do daily is continued for 8weeks
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	35 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy females aged from 35 to 45 years old. 2. Person whose skin with chapping or person with dry skin. 3. Person with sensitive skin. 4. Person who is sensitive to physical change. 5. People who are interested in relaxation and have will to continue it.
Key exclusion criteria	1.Person who have abnormalities in the skin of a measured region 2.Person who are out patients. 3.Person with experience of relaxation. 4.Person who have possibilities for emerging allergy to cosmetics. 5.Persons had cosmetic surgery in the past year. 6.Person who participate in the other clinical studies within 4 weeks in the past, or person who have a schedule which participates in other clinical studies during a test period. 7.Those to whom the person himself/herself and a family are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company. 8.person with dependence on caffeine 9.Current smoker
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Sakai
Organization	Kao Corporation
Division name	Skincare Products Research
Zip code	250-0002
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, Japan
TEL	+81-465-34-6433
Email	sakai.shingo2@kao.co.jp

Public contact
Name of contact person	1st name Mayumi Middle name Last name Inoue
Organization	Kao Corporation
Division name	Skincare Products Research
Zip code	250-0002
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, Japan
TEL	+81-465-34-6433
Homepage URL
Email	inoue.mayumi1@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	701 Research Inc.
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	morisaki.naoko@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	株式会社セブンオーワンリサーチ/Above Access（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 15 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	40
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 12 Month 14 Day
Date of IRB	2018 Year 12 Month 14 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2019 Year 05 Month 26 Day
Date of closure to data entry	2019 Year 07 Month 19 Day
Date trial data considered complete	2019 Year 08 Month 21 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 12 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040833