Efficacy and Safety of Stylage XL Lidocaine for the Restoration and/or Augmentation of Facial Volume: The Beauty Volume Study

Abstract

Abstract Background Hyaluronic acid (HA)-based gel fillers help correct facial volume deficits through their volumizing effect. Objectives This postmarket clinical follow-up study was a single-center prospective cohort study designed to evaluate the efficacy and safety of Stylage XL Lidocaine (Laboratoires VIVACY, Paris, France) for the augmentation and/or restoration of facial volume. Methods Healthy patients aged between 30 and 65 years with a facial volume grade of 3 to 5 according to the facial volume loss scale (FVLS) were considered eligible. Participants were injected subcutaneously in the area of the cheekbones (essential area). If necessary, patients were also injected in the chin, the temples, and the facial oval (optional areas). Outcomes were assessed at 1, 3, 6, 12, and 18 months following the initial treatment. A touch-up was possible at 1 month following the initial injection. The primary endpoint was the variation in the mean FVLS scores at M6 compared to baseline as evaluated by an independent assessor. Results A total of 40 female patients (mean age of 52.5 years) were recruited between November 2019 and July 2021. There was a significant improvement in the mean FVLS score at 6 months compared to baseline (2.3 [0.6] vs 3.1 [0.6]; P < .0001). Patients were satisfied with the achieved aesthetic improvements and results were still observed at 12 and 18 months. Stylage XL Lidocaine also had a good safety profile and was well tolerated by the study cohort. Conclusions The results of the 18-month Beauty Volume study confirmed the efficacy and safety of the Stylage XL Lidocaine HA-based gel filler in the augmentation and/or restoration of facial volumes. Level of Evidence: 3