Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059536) titled 'A Single-center Randomized Controlled Trial of Platelet-Rich Plasma Combined Fat Grafting for Forehead Augmentation' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic

Condition: Condition - Skin tissue exhibiting atrophy or deformity caused by aging, trauma, or congenital abnormalities. Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068098

Disclaimer: Curated by HT Syndication.