UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042999 |
|---|---|
| Receipt number | 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 | 2024/01/18 21:24:09 |
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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
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
t-oishi@pola.co.jp
Sponsor or person
Institute
POLA CHEMICAL INDUSTRIES, INC.
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048743
