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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||
Condition | Healthy volunteer | ||||
Classification by specialty |
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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
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |