UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018887 |
|---|---|
| Receipt number | 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 10:40:02 |
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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
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
info@colsys.co.jp
Sponsor or person
Institute
Col Sys Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021852
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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