UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022134 |
|---|---|
| Receipt number | R000025511 |
| Scientific Title | Observation of relation between stress, autonomic nerve activity, and skin condition. |
| Date of disclosure of the study information | 2016/05/12 |
| Last modified on | 2016/10/28 10:56:47 |
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Basic information
Public title
Observation of relation between stress, autonomic nerve activity, and skin condition.
Acronym
Observation of relation between stress, autonomic nerve activity, and skin condition.
Scientific Title
Observation of relation between stress, autonomic nerve activity, and skin condition.
Scientific Title:Acronym
Observation of relation between stress, autonomic nerve activity, and skin condition.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Grasp of the relationship of the autonomic nerve activity and a skin condition at the time of sensing stress.
Basic objectives2
Others
Basic objectives -Others
Observation of actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heartbeat, horny cell layer moisture content, trans epidermal water loss, sebum, component of a cutaneous secretion , recovery rate of skin temperature after cooling, interview and questionnaire about skin condition, stress and body condition.
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 of heartbeat, horny cell layer moisture content, trans epidermal water loss, sebum, component of a cutaneous secretion , recovery rate of skin temperature after cooling.
-Interview and questionnaire about skin condition, stress and body condition.
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
| 30 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
-Persons who are healthy and have full time work.
-Persons who sense the stress by hard work one day or more of weeks.
-Persons who have aggravation of sleep quality and skin condition when they sense the stress by hard work.
-Persons who think own skin type is dry skin or combination skin.
Key exclusion criteria
-Patients with atopic dermatitis.
-Persons of skin to whom skin troubles by cosmetics happens easily.
-Persons who have severe allergic disease as pollen allergy, rhinitis, atopicdermatitis.
-Patients with vascular function disorder.
-Persons who have severe poor circulation.
-Persons who have problems with electrocardiogram test such as arrhythmia.
-The person who went to hospital regularly to the medical institution within the past one month.
-Persons who have received a cosmetic medicine.
-Current smoker
-Persons who have a less than 3-year-old child.
-Persons to whom a life becomes irregular easily by child-rearing or care.
-Persons who are pregnant or lactating, or plan to become pregnant in the near future.
-Persons who may do suntan remarkably exceeding everyday life.
-Persons who may eat stimulus (ginger, mustard, pepper, capsici fructus, japanese horseradish, etc.) and foods containing caffeine (energy drink, tea, coffee, etc.), remarkably exceeding everyday intake.
-Persons who do face shaving, esthetic program and peeling periodically or planned to do them in exam period.
-Persons to whom the person himself/herself or a family is engaged in an advertising agency, investigation and consultant business, mass media, and food, cosmetics and the health article manufacturing industry.
-Persons who plan to become participates in the other clinical studies or exam.
-Persons who are judged as unsuitable for the study by investigator
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Kataoka |
Organization
Kao Corporation
Division name
R&D -Development Research- Health Beauty Products Research
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-9581
kataoka.kiyoshi@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Moriai |
Organization
Kao Corporation
Division name
R&D -Development Research- Health Beauty Products Research
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-9581
Homepage URL
moriai.yasuo@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
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
花王株式会社ソフトリサーチセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 12 | 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 | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 13 | 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 | 04 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025511
