Efficacy and Safety of a Poly-L-Lactic Acid Filler for Temporal Augmentation: A Randomized, No-treatment Control, Evaluator-blinded, Multicenter Study.

Abstract

Temple hollowing represents a prevalent aesthetic concern traditionally addressed with autologous fat grafting or hyaluronic acid fillers. Poly-L-lactic acid (PLLA) offers gradual, collagen-mediated volumization and is increasingly utilized for soft tissue augmentation. Nevertheless, to date, no approved study has evaluated its use for temporal augmentation. The aim of this study was to evaluate the efficacy and safety of a PLLA facial filler for the augmentation of temple hollowing. This randomized, no-treatment control, evaluator-blinded, multicenter clinical trial enrolled 174 participants with moderate to severe temple hollowing, randomized 2:1 to the treatment or control group. The treatment group received 2 to 3 sessions of PLLA bilateral temporal injections with 12-month follow-up, and the control group received no treatment within 6 months after randomization. Efficacy was assessed with the Allergan Temple Hollowing Scale (ATHS), Global Aesthetic Improvement Scale (GAIS), 3-dimensional (3D) volume change of temples, and participant-reported satisfaction. Safety evaluations included adverse events (AEs), injection-site reactions, vital signs, and laboratory tests. At Month 6, 96.5% of participants in the treatment group achieved an at least 1-grade improvement on the ATHS, in contrast to 0% in the control group (P < .0001). Consistent and significant improvements were observed across all secondary endpoints, including ATHS efficacy rates assessed by both blinded evaluators and injection investigators at all follow-up visits up to 12 months, GAIS improvement rates, and temporal volume measured by 3D imaging. Aesthetic improvement and participant satisfaction were rated highly at all follow-up visits. PLLA was safe and well tolerated, with no therapy-related adverse events reported. PLLA facial filler effectively improved temple hollowing and achieved aesthetic enhancement for up to 12 months, with an excellent safety profile. (Therapeutic)For image description, please refer to the figure legend and surrounding text.