UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032066
Receipt number R000036581
Scientific Title Evaluation of the effect of slack of face by Gua Sha treatment
Date of disclosure of the study information 2018/04/04
Last modified on 2020/03/19 18:05:20

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Basic information

Public title

Evaluation of the effect of slack of face by Gua Sha treatment

Acronym

Evaluation of the effect of slack of face by Gua Sha treatment

Scientific Title

Evaluation of the effect of slack of face by Gua Sha treatment

Scientific Title:Acronym

Evaluation of the effect of slack of face by Gua Sha treatment

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Subjects who have slack in their face use Gua Sha and evaluate the effect on the skin

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measure face line angle and compare within group

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

Massage with using Gua Sha and cosmetics

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

28 years-old <=

Age-upper limit

59 years-old >=

Gender

Female

Key inclusion criteria

Subjects wishing for facial wrinkles, face slack care

Key exclusion criteria

1. Subjects with cosmetic allergies
2. Subjects who are pregnant or lactating
3. Subjects with inflamed or scraped skin on face
4. Subjects who are judged as unsuitable for the study by the investigator for the other reason

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatomo Najima

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Email

info@yakujihou.org


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Kaneko

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Homepage URL


Email

info@yakujihou.org


Sponsor or person

Institute

Japan Clinical Trial Association

Institute

Department

Personal name



Funding Source

Organization

MTG CO.,LTD.

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



Other administrative information

Date of disclosure of the study information

2018 Year 04 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

Completed

Date of protocol fixation

2018 Year 03 Month 15 Day

Date of IRB

2018 Year 03 Month 15 Day

Anticipated trial start date

2018 Year 04 Month 04 Day

Last follow-up date

2018 Year 04 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 02 Day

Last modified on

2020 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036581


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name