NCT06948045

RESTRUCTURING THE MANDIBULAR ANGLE IN FACIAL AGING: A NOVEL TECNIQUE USING POLY-L-LACTIC ACID

Restructuring the Mandibular Angle in Facial Aging: a Novel Tecnique Using Poly-L-Lactic Acid

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Doris Hexsel · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Skin laxity is a common complaint among patients seeking aesthetic dermatological interventions, affecting the facial contour, especially in the mandibular angle, due to bone aging and the loss of tissue support in the lower third of the face. Facelift surgery is an effective method to address this issue, but it is invasive and may impact the definition of the jawline. As an alternative, poly-L-lactic acid (PLLA) stimulates collagen production, improving facial contour in a minimally invasive manner. This study aims to evaluate the safety and effectiveness of a new, low-cost, and quick application technique using poly-L-lactic acid in the mandibular angle and anterior to the mandibular ligament. The proposed technique seeks to enhance facial contour, provide an additional lifting effect, and contribute to overall facial rejuvenation. This is a clinical, prospective, and interventional study, allowing the analysis of clinical outcomes in terms of efficacy and safety. Twenty volunteers aged between 18 and 65, of both genders, with no restrictions on the use of collagen bio-stimulators, will be recruited. After confirming inclusion and exclusion criteria, participants will sign the Informed Consent Form (ICF) and be eligible for the study. The first intervention will occur at visit 2 (day 1), the second intervention at visit 3 (day 30 ± 15), and the third intervention will be performed as indicated at visit 4 (day 60 ± 15). Final follow-up will take place at visit 5 (day 90 ± 15). Questionnaires will be applied and photographs taken at all visits. Injections will be administered with poly-L-lactic acid in the mandibular angle region and anterior to the mandibular ligament. The study will be funded by the Research Department of the Hexsel Dermatology Clinic, and the data collected will be used to prepare an article for publication.

Conditions

• Skin Laxity
• Facial Aging

Interventions

Type	Name	Description
PROCEDURE	PLLA application to the mandibular angle	The investigator will mark the application area by palpating the inferior and posterior boundaries of the face and the mandibular ramus, approximately 1 cm from these anatomical landmarks. The second PLLA injection point will be marked 1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament. The demarcated area will be anesthetized with a local infiltration of 0.3-0.5 mL of 1% lidocaine with epinephrine, using a 30G needle. PLLA will then be reconstituted in 10 mL of sterile water for injection. Administration will be performed with a 30G needle inserted perpendicularly into the marked area until the supraperiosteal plane of the mandibular angle is reached, delivering a 0.7 mL bolus of the reconstituted product. At the second site-1 cm from the inferior bony border of the mandible, anterior to the mandibular ligament-a 0.2 mL dose of the reconstituted product will be injected.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2025-04-29
• Last updated: 2025-11-26

Regulatory

• FDA-regulated device study