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A Single-center Prospective Non-randomized Comparative Study Evaluating Fat Graft Retention in PRP-Assisted Forehead Augmentation.

A Single-center Prospective Non-randomized Comparative Study Evaluating Fat Graft Retention in PRP-Assisted Forehead Augmentation. - A Single-center Prospective Non-randomized Comparative Study Evaluating Fat Graft Retention in PRP-Assisted Forehead Augmentation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059536
Enrollment
20
Registered
2025-10-24
Start date
2025-03-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin tissue exhibiting atrophy or deformity caused by aging, trauma, or congenital abnormalities.

Interventions

Fat Grafting with Platelet-Rich Plasma (PRP) [Harvesting and Processing of Fat] Adipose tissue is harvested from the inner thigh, abdomen, or buttocks, depending on the patient&#39
s body habitus and condition of the donor site, under appropriate anesthesia. The volume of harvested fat is approximately 30-50 mL. The harvested fat is processed by centrifugation or equivalent meth

Sponsors

Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
3D images of the treated area will be obtained preoperatively, immediately after surgery, and at 1, 3, and 6 months postoperatively using a 3D camera system, and fat volume will be measured. Fat graft retention will be defined as the ratio of the fat volume at each postoperative time point to the volume measured immediately after surgery, and this will be used as the primary outcome.

Secondary

MeasureTime frame
1. The incidence of complications during the entire observation period, including fat necrosis and nodule formation, will be recorded and evaluated. 2. Image evaluation using the neoVoir imaging system will be performed preoperatively and at 1, 3, and 6 months postoperatively. 3. Patient satisfaction will be evaluated at 1, 3, and 6 months postoperatively using a standardized questionnaire.

Countries

Japan

Contacts

Public ContactMasashi Umeda

Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic

dr.umeda.masashi@tcb.or.jp06-6147-2581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026