UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025812
Receipt number 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 16:41:04

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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 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


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

Value
https://center6.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