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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036833
Receipt No. 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

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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
Email 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
Email yoshika@yahoo.co.jp

Sponsor
Institute KITASATO UNIVERSITY,SCHOOL OF MEDICINE
KITASATO UNIVERSITY,KITASATO Insutitute Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041961

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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