UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058413 |
|---|---|
| Receipt number | R000066783 |
| Scientific Title | Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/09 17:46:02 |
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Basic information
Public title
Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation
Acronym
Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation
Scientific Title
Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation
Scientific Title:Acronym
Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation
Region
| Japan |
Condition
Condition
Skin tissue that has atrophied or changed due to aging, trauma, congenital etc.
Classification by specialty
| Dermatology | Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will use a prospective survey based on patient data to examine the effectiveness of PRP treatment on skin tissue that has atrophied or been deformed due to aging, trauma, congenital conditions, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Photographs and a patient satisfaction survey will be conducted at 1 month, 3 months, and 6 months after the start of 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
PRP is prepared using the patient's own blood as the source material.
The prepared PRP is then administered to the patient's face.
Injection is performed on both the right and left sides of the face as follows:
Right side: PRP
Left side: Normal saline
The injections are performed using a mesotherapy device, with the target depth being the dermal layer.
The volume of PRP administered ranges from 1 to 6 mL, depending on the size and condition of the treated area.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following criteria
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
10
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@cybervision21.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Umeda |
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.umeda.masashi@cybervision21.com
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
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@medical-frontier.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 | 07 | Month | 09 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066783
