UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024921 |
|---|---|
| Receipt number | R000028672 |
| Scientific Title | A Study on the skin effect by relaxation (2) |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2017/05/24 12:56:16 |
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Basic information
Public title
A Study on the skin effect by relaxation (2)
Acronym
A Study on the skin effect by relaxation (2)
Scientific Title
A Study on the skin effect by relaxation (2)
Scientific Title:Acronym
A Study on the skin effect by relaxation (2)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the dermatological efficacy of relaxation for healthy female face
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color, the skin viscoelasticity, the stratum corneum cell size, skin temperature, heart rate, salivary component and the psychological assessment after the repeated relaxation for 8week.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Relaxation is performed before every skin care for 8 weeks
Interventions/Control_2
Resting with closing eyes is performed before every skin care for 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Healthy females aged from 40 to 59 years old.
2. After menopause
3. Person whose skin with chapping or person with dry skin.
4. Person with sensitive skin.
5. Person who have trouble about mind and body.
6. 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. Person who are take a drug prescribed by doctor .
8. 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.
9. person with dependence on caffeine
10. Current smoker
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Sugiyama |
Organization
Kao Corporation
Division name
R&D Health Beauty Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-9534
sugiyama.yoshinori@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Inoue |
Organization
Kao Corporation
Division name
R&D Health Beauty Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-9534
Homepage URL
inoue.mayumi1@kao.co.jp
Sponsor or person
Institute
701 Research Inc.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 01 | 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
| 2016 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2017 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
