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

Email

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


Email

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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name