UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036833 |
|---|---|
| Receipt number | R000041961 |
| Scientific Title | Aesthetics medical education program construction by department of Plastic and Aesthetic Surgery Kitasato University school of medicine -focusing on filler treatment- |
| Date of disclosure of the study information | 2019/05/23 |
| Last modified on | 2019/05/23 18:23:01 |
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Basic information
Public title
Aesthetics medical education program construction by department of Plastic and Aesthetic Surgery Kitasato University school of medicine -focusing on filler treatment-
Acronym
Aesthetics medical education program construction by department of Plastic and Aesthetic Surgery Kitasato University school of medicine -focusing on filler treatment-
Scientific Title
Aesthetics medical education program construction by department of Plastic and Aesthetic Surgery Kitasato University school of medicine -focusing on filler treatment-
Scientific Title:Acronym
Aesthetics medical education program construction by department of Plastic and Aesthetic Surgery Kitasato University school of medicine -focusing on filler treatment-
Region
| Japan |
Condition
Condition
aging face
Classification by specialty
| Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct doctor's education centering on filler therapy.Development of effective treatment using MHLW approved products and improvement of filler technology, and we will work on this educational program with the aim of developing medical care with high safety.
Basic objectives2
Others
Basic objectives -Others
Providing as a university hospital information and research that maximizes doctor's knowledge and skills in cosmetic medicine.To this end, invite famous foreign doctors and share knowledge.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Invited foreign doctors who are famous for filler therapy,Hold an injection seminar.Once every four months, about three times a year,Provide information and research opportunities that bring the doctor's knowledge and skills to the highest level.
Key secondary outcomes
Skin findings, analysis of stains and wrinkles on the skin using digital camera images, and survey subjects (monitor) questionnaires.Each injection before injection, once every two weeks after injection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Duration of intervention for individual subjects.Only once at the time of the seminar.Dosage (until 1 to 20 cc of hyaluronic acid, 100 units of Botox)Time (about 15 minutes to 1 hour in one treatment)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are judged to have wrinkles or sagging in Department of Plastic and Aesthetic Surgery Kitasato University kitasato Institute Hospital and Kitasato University,school of medicine and wish to treat them.
Patients who have agreed as research subjects (monitors) of the seminar according to this program.
Key exclusion criteria
If you have a generalized muscle disease
Those who are pregnant or may be pregnant, and who are nursing
If you have used allergy to this drug before or if you are allergic
If you have chronic respiratory disease such as asthma, or if you have glaucoma
Person who has a history of hypersensitivity to the ingredients of this product or to the amide type local anesthetic
Persons who have a history of hypersensitivity to proteins derived from gram-positive bacteria
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takeda |
Organization
Kitasato university,school of medicine
Division name
DEPARTMENT OF Plastic & Aesthetic Surgery
Zip code
2520374
Address
1-15-1 Kitasato,minami-ku,Sagamihara-city,Kanagawa
TEL
0427789074
takeda@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | yoshika |
| Middle name | |
| Last name | sugimoto |
Organization
KITASATO UNIVERSITY,SCHOOL OF MEDICINE
Division name
DEPARTMENT OF Plastic & Aesthetic Surgery
Zip code
2520374
Address
1-15-1 Kitasato,minami-ku,Sagamihara-city,Kanagawa
TEL
0427789074
Homepage URL
yoshika@yahoo.co.jp
Sponsor or person
Institute
KITASATO UNIVERSITY,SCHOOL OF MEDICINE
KITASATO UNIVERSITY,KITASATO Insutitute Hospital
Institute
Department
Personal name
Funding Source
Organization
allergan.jp
galderma.jp
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
KITASATO UNIVERSITY,SCHOOL OF MEDICINE
Address
1-15-1 Kitasato,minami-ku,Sagamihara-city,Kanagawa
Tel
0427789074
yoshika@yahoo.co.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
| 2019 | Year | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041961
| 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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| Registered date | File name |
