UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035846 |
|---|---|
| Receipt number | R000040833 |
| Scientific Title | A Study on the effect by skincare method based on autogenic training principle. |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2020/04/06 18:17:01 |
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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
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
inoue.mayumi1@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040833
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