UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028045
Receipt number R000032084
Scientific Title Effects of cosmetic treatment on somatopsychology.
Date of disclosure of the study information 2017/07/04
Last modified on 2023/07/20 11:37:11

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Basic information

Public title

Effects of cosmetic treatment on somatopsychology.

Acronym

Effects of cosmetic treatment on somatopsychology.

Scientific Title

Effects of cosmetic treatment on somatopsychology.

Scientific Title:Acronym

Effects of cosmetic treatment on somatopsychology.

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate effects of cosmetic treatment on somatopsychology.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in skin quality

Key secondary outcomes

1.Near Infrared Spectroscopy
2.Heart rate variability
3.Profile of Mood States
4.State Trait Anxiety Inventory
5.Chinese medicine questionnaire


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Cosmetic treatment

Interventions/Control_2

no treatment

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy person

Key exclusion criteria

Subjects who have history of cerebrovascular or psychiatric disorder.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Arima

Organization

Suzuka University of Medical Science

Division name

Institute of Traditional Chinese Medicine

Zip code

510-0226

Address

1275-3, Kishioka,Suzuka-city, Mie, JAPAN

TEL

059-381-2385

Email

maning@suzuka-u.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name kawanokuchi

Organization

Suzuka University of Medical Science

Division name

Institute of Traditional Chinese Medicine

Zip code

510-0226

Address

1275-3, Kishioka,Suzuka-city, Mie, JAPAN

TEL

059-381-2385

Homepage URL


Email

kawa-jun@suzuka-u.ac.jp


Sponsor or person

Institute

Suzuka University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Suzuka University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suzuka University of Medical Science

Address

1275-3, Kishioka,Suzuka-city, Mie, JAPAN

Tel

059-381-2385

Email

kawa-jun@suzuka-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 04 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

Terminated

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 11 Month 01 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2023 Year 07 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 03 Day

Last modified on

2023 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name