UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029666
Receipt number R000033801
Scientific Title A Study on relationship between skincare motion and psychological, physical and dermatological function.
Date of disclosure of the study information 2017/11/01
Last modified on 2017/11/16 11:14:38

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Basic information

Public title

A Study on relationship between skincare motion and psychological, physical and dermatological function.

Acronym

Efficacy test of skincare for relaxation.

Scientific Title

A Study on relationship between skincare motion and psychological, physical and dermatological function.

Scientific Title:Acronym

Efficacy test of skincare for relaxation.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the relaxation efficacy of skincare for healthy female

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relation between change of skincare motion and change of autonomic activity after skincare

Key secondary outcomes

Properties of skincare motion related to autonomic activity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

For the participant who has positive impression to skin care, they have to accept the procedure (face-washing->skin-measurement->face-washing->autonomic measurement->skincare with test product->autonomic measurement)

Interventions/Control_2

For the participant who has positive impression to skin care, they have to accept the procedure (face-washing->skin-measurement->face-washing->autonomic measurement->skincare with user's product->autonomic measurement)

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

49 years-old >=

Gender

Female

Key inclusion criteria

Healthy females

Key exclusion criteria

-Subjects with atopic dermatitis, eczema and pollen allergy
-Subjects deemed inappropriate to participate in this study by the principle investigator
-Subjects with abnormal blood pressure
-Subjects with abnormal BMI

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Sakai

Organization

Kao Corporation

Division name

Skincare Products Research

Zip code


Address

5-3-28, kotobuki-cho, odawara, 250-0002, Japan

TEL

+81-465-35-3175

Email

sakai.shingo2@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mika Nomura

Organization

Kao Corporation

Division name

Skincare Products Research

Zip code


Address

5-3-28, kotobuki-cho, odawara, 250-0002, Japan

TEL

+81-465-34-8941

Homepage URL


Email

nomura.mika@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 11 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

2017 Year 09 Month 25 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 02 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

2017 Year 10 Month 23 Day

Last modified on

2017 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name