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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042999
Receipt No. R000048743
Scientific Title A prospective observational study of changes in physical property of skin before and after fat injection into the eye bag
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/14

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Basic information
Public title A prospective observational study of changes in physical property of skin before and after fat injection into the eye bag
Acronym A prospective observational study of changes in physical property of skin before and after fat injection into the eye bag
Scientific Title A prospective observational study of changes in physical property of skin before and after fat injection into the eye bag
Scientific Title:Acronym A prospective observational study of changes in physical property of skin before and after fat injection into the eye bag
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Dermatology Plastic surgery Aesthetic surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the changes in physical properties of skin before and after fat injection into the eye bags
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in physical properties of skin before and after fat injections to the eye bags
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria Subjects who meet all of the following criteria at the time of obtaining consent will be included in this study
1) Japanese women aged between 40 and 59 years
2) Subjects who plan to undergo fat injection surgery for eye bags
3) Subjects who have received written consent to participate in this study
Key exclusion criteria Subjects who do not meet any of the following exclusion criteria at the time of consent acquisition will be included in this study
1) Pregnant or lactating women
2) Subjects with skin diseases such as atopic dermatitis and psoriasis on the face
3) Subjects who plan to undergo facial cosmetic procedures (including aesthetic and laser treatments) during the observation period of this study
4) Subjects who have participated in clinical trials and have participated in clinical trials within 3 months before the start of this study
5) Any other subjects who is judged by the principal investigator to be inappropriate to participate in this study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tomomasa
Middle name
Last name Shimanuki
Organization POLA CHEMICAL INDUSTRIES, INC.
Division name Frontier Research Center
Zip code 244-0812
Address 560 Kashio-cho, Totsuka-ku, Yokohama-shi, Kanagawa, Japan
TEL 045-826-7231
Email t-shimanuki@pola.co.jp

Public contact
Name of contact person
1st name Takaya
Middle name
Last name Oishi
Organization POLA CHEMICAL INDUSTRIES, INC.
Division name Frontier Research Center
Zip code 244-0812
Address 560 Kashio-cho, Totsuka-ku, Yokohama-shi, Kanagawa, Japan
TEL 045-826-7134
Homepage URL
Email t-oishi@pola.co.jp

Sponsor
Institute POLA CHEMICAL INDUSTRIES, INC.
Institute
Department

Funding Source
Organization POLA CHEMICAL INDUSTRIES, INC.
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 Non-Profit Organization MINS Institutional Review Board
Address 5-20-9-401,Mita,Minato-ku,Tokyo,Japan
Tel 03-6416-1868
Email npo-mins@j-irb.com

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 THE CLINIC 東京院(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 14 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 10 Day
Date of IRB
2020 Year 11 Month 19 Day
Anticipated trial start date
2021 Year 01 Month 14 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The following information will be collected before, 28 days, and 84 days after the fat injection procedure.
Background information of subjects/questionnaires/skin physical test/adverse events

Management information
Registered date
2021 Year 01 Month 14 Day
Last modified on
2021 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048743

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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