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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025812
Receipt No. R000029684
Scientific Title A study for relationships between skin condition and blood flow (2017).
Date of disclosure of the study information 2017/02/13
Last modified on 2017/07/24

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Basic information
Public title A study for relationships between skin condition and blood flow (2017).
Acronym A study for relationships between skin condition and blood flow (2017).
Scientific Title A study for relationships between skin condition and blood flow (2017).
Scientific Title:Acronym A study for relationships between skin condition and blood flow (2017).
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the relationships between skin condition, blood flow and autonomic nervous activity.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the stratum corneum water content, transepidermal water loss, sebum secretion, skin color, skin viscoelasticity, skin texture, stratum corneum cell size and composition, blood flow measurements, autonomic nervous activity, dermatological assessment, salivary component and body composition.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
69 years-old >=
Gender Female
Key inclusion criteria 1. Healthy female aged from 20 to 69 years old.
2. Person who can agree to participate in the study voluntarily in writing.
3. Person who can agree to be taken several pictures including their face.
4. Person who has no trouble in the skin of test sites (face and arms).
Key exclusion criteria 1. Person who has abnormalities in the skin of the test region
2. Person who regularly goes to hospital.
3. Person with the anamnesis of an alcohol or drug dependence.
4. Person who regularly use drug (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc..).
5. Person who has allergy to adhesive tape, medical tape and/or rubber.
6. Person who suffers pollen allergy, rhinitis and/or atopic dermatitis.
7. Person who is pregnant or lactating.
8. Person who participates in the other clinical studies within 4 weeks in the past.
9. Person who is judged as unsuitable for the study by the investigator for other reasons.
10. Person who herself and/or her family member are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
11. Patient with vascular function disorder, or person who has excessive sensitivity to cold.
12. Person who has abnormal blood pressure or electrocardiogram testing result.
13. Person who experienced medical cosmetic treatment (i.e. cosmetic surgery, collagen injection etc.)
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Sugiyama
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code
Address 5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL 0465-35-3175
Email sugiyama.yoshinori@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Amano
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code
Address 5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL 0465-35-3175
Homepage URL
Email amano.yasuko@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 13 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 01 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information participants will be recruited by SOUKEN

Management information
Registered date
2017 Year 01 Month 23 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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