UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058677 |
|---|---|
| Receipt number | R000067012 |
| Scientific Title | Efficacy of PRP Injection in Treating Scar Contracture After Liposuction:A Self-Controlled Prospective Evaluation |
| Date of disclosure of the study information | 2025/08/02 |
| Last modified on | 2025/10/17 12:20:37 |
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Basic information
Public title
Efficacy of PRP Injection in Treating Scar Contracture After Liposuction:A Self-Controlled Prospective Evaluation
Acronym
Efficacy of PRP Injection in Treating Scar Contracture After Liposuction:A Self-Controlled Prospective Evaluation
Scientific Title
Efficacy of PRP Injection in Treating Scar Contracture After Liposuction:A Self-Controlled Prospective Evaluation
Scientific Title:Acronym
Efficacy of PRP Injection in Treating Scar Contracture After Liposuction:A Self-Controlled Prospective Evaluation
Region
| Japan |
Condition
Condition
Scar Contracture After Liposuction
Classification by specialty
| Surgery in general | Dermatology | Aesthetic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Through a prospective design, this study examines the therapeutic efficacy of PRP injection for scars and scar contracture occurring after liposuction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity is measured preoperatively, and at 1 month, 3 months, and 6 months postoperatively.
patient-reported outcomes and clinician-reported outcomes are assessed one month after the treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Equal quantities of fat are aspirated from both inner thighs.
PRP or saline was injected into the liposuction site.
Right side: saline 6mL
Left side: PRP 6mL
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following criteria:
･wish to undergo liposuction
･Have clear tissue deformity or atrophy due to congenital conditions, trauma, or aging
･Are expected to benefit from this treatment
･Wish to receive the treatment and have been deemed suitable for it by a physician
･Are able to attend outpatient visits
･adults
･Have provided written informed consent for this treatment
Key exclusion criteria
･Have a clearly apparent infection in the area surrounding the injection site
･Have a predisposition to keloid formation
･Have an insufficient understanding of this treatment
･Lack the capacity to make an informed decision regarding this treatment
･Do not wish to receive this treatment or are unable to provide informed consent
･Are deemed inappropriate for the treatment by the physician, such as those with malignant tumors, infectious tumors, infectious diseases, or inflammatory diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@tcb.or.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Tamura |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.tamura.taichi@tcb.or.jp
Sponsor or person
Institute
TCB Tokyo chuo beauty clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2025 | Year | 08 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067012
