UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059536 |
|---|---|
| Receipt number | R000068098 |
| Scientific Title | A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation. |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/24 16:35:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation.
Acronym
A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation.
Scientific Title
A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation.
Scientific Title:Acronym
A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation.
Region
| Japan |
Condition
Condition
Skin tissue exhibiting atrophy or deformity caused by aging, trauma, or congenital abnormalities.
Classification by specialty
| Dermatology | Plastic surgery | Aesthetic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regenerative medicine has been rapidly developing in the field of aesthetic medicine. Among these techniques, platelet-rich plasma (PRP)-based regenerative therapy, classified as Class III under the Act on the Safety of Regenerative Medicine in Japan, has been widely applied in clinical practice because of its minimally invasive nature and favorable safety profile. However, scientific evidence supporting the clinical efficacy of PRP therapy remains insufficient.
Preclinical studies have demonstrated that the combination of PRP with autologous fat grafting enhances fat graft survival, possibly through angiogenic and tissue repair-promoting effects.
The present study aims to evaluate the efficacy and safety of PRP-assisted fat grafting for forehead augmentation through a single-center randomized controlled interventional trial, comparing PRP-combined fat injection with fat-only injection. Quantitative assessments of graft retention, complication rates, and patient satisfaction will be performed to establish clinical evidence for PRP-assisted regenerative therapy in aesthetic applications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A 3D camera will be used to obtain images of the treated region before and immediately after surgery, and at 1, 3, and 6 months postoperatively for volumetric analysis of the grafted fat.
Key secondary outcomes
1.Investigation of the incidence of complications (such as fat necrosis and nodule formation) throughout the entire study period
2.Image analysis using the imaging device neoVoir at preoperative and postoperative months 1, 3, and 6
3.Evaluation of patient satisfaction at postoperative months 1, 3, and 6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Fat plus PRP Group (Intervention group)
[Fat harvesting and purification]
Autologous fat is harvested from the subcutaneous layer of the medial thigh, abdomen, or buttock, selected according to the patient's body habitus and the condition of each donor site. Approximately 30-50 mL of fat is aspirated under anesthesia. The harvested fat is purified by centrifugation to remove oil and blood components before transplantation.
[Preparation and mixing of PRP]
Autologous venous blood is collected and centrifuged to obtain platelet-rich plasma (PRP). The prepared PRP is added to the purified fat and gently mixed to ensure homogeneity throughout the adipose tissue.
[Injection procedure]
The PRP-enriched fat is loaded into a syringe and injected into the subcutaneous layer of the forehead using a microcannula, evenly distributed through the insertion site. Each treatment is performed as a single session, followed by postoperative observation.
Interventions/Control_2
Fat-only Group (Control group)
[Fat harvesting and purification]
Fat harvesting and purification are performed in the same manner as in the intervention group, from the medial thigh, abdomen, or buttock. The volume of fat collected, processing method, and injection procedure are identical to those used in the intervention group, except that no PRP is added.
[Injection procedure]
Purified fat is loaded into a syringe and injected into the subcutaneous layer of the forehead using a microcannula in a single session.
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
1.Adult patients who desire forehead fat grafting and undergo the procedure.
2.Patients who provide written informed consent to participate in the study.
3.Patients with apparent tissue deformity or atrophy of the forehead due to congenital factors, trauma, or aging.
4.Patients expected to benefit from the treatment.
5.Patients who wish to receive this treatment and are deemed suitable candidates by the physician.
6.Patients who are able to attend follow-up visits on an outpatient basis.
Key exclusion criteria
1.Patients who have previously undergone fat grafting to the forehead.
2.Patients who have received hyaluronic acid filler injections to the forehead within the past 12 months.
3.Patients who have received botulinum toxin (Botox) injections to the forehead within the past 4 months.
4.Patients who undergo any additional procedures such as fat grafting, hyaluronic acid filler injection, or botulinum toxin injection to the forehead during the observation period after treatment.
5.Patients with a body mass index (BMI) below 18 or above 30.
6.Patients with bleeding disorders or autoimmune diseases.
7.Patients currently taking antithrombotic medications.
8.Patients with diseases that are contraindications for platelet-rich plasma (PRP) therapy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
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 | Masashi |
| Middle name | |
| Last name | Umeda |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
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@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae 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 | 10 | Month | 24 | 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
| 2025 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 20 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068098
