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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018887
Receipt No. R000021852
Scientific Title The prospective cohort study on the feasibility of simplified facial image evaluation method for quantitative evaluation of facial massage
Date of disclosure of the study information 2015/09/02
Last modified on 2015/09/02

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Basic information
Public title The prospective cohort study on the feasibility of simplified facial image evaluation method for quantitative evaluation of facial massage
Acronym The prospective cohort study on the feasibility of simplified facial image evaluation method
Scientific Title The prospective cohort study on the feasibility of simplified facial image evaluation method for quantitative evaluation of facial massage
Scientific Title:Acronym The prospective cohort study on the feasibility of simplified facial image evaluation method
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Feasibility
Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Feasibility of Image analysis
Key secondary outcomes Reproducibility between pre and post procedure
Adverse event
Lower jaw pulling up between pre and post procedure
Mouth corner pulling up between pre and post procedure

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Facial massage
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

Not applicable
Gender Female
Key inclusion criteria Patients who underwent facial massage
Key exclusion criteria consent has not been obtained
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mako Yamada
Organization Col Sys Co., Ltd.
Division name President
Zip code
Address 1203 Grand Pier Nishi-Ohashi, 2-2-28, Kita-Horie, Nishi-Ku, OSAKA, JAPAN
TEL 06-6536-3480
Email info@colsys.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mako Yamada
Organization Col Sys Co., Ltd.
Division name President
Zip code
Address 1203 Grand Pier Nishi-Ohashi, 2-2-28, Kita-Horie, Nishi-Ku, OSAKA, JAPAN
TEL 06-6536-3480
Homepage URL
Email info@colsys.co.jp

Sponsor
Institute Col Sys Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Society for Aging Image
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
2015 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 12 Day
Last follow-up date
2014 Year 11 Month 18 Day
Date of closure to data entry
2015 Year 08 Month 23 Day
Date trial data considered complete
2015 Year 08 Month 23 Day
Date analysis concluded
2015 Year 08 Month 25 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 02 Day
Last modified on
2015 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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