UMIN-CTR Clinical Trial

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

Contact us.