$332.00
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Hyaluronic acid (HA)-based gel fillers help correct facial volume deficits through their volumizing effect.
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.
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.
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.
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.
The loss of facial volume is a well-known sign of the aging process. Facial volume loss is becoming an increasingly important issue as people are not only living increasingly longer, but are also leading a more active lifestyle both socially and professionally.1 Hyaluronic acid (HA)-based gel fillers can help correct this volume deficit through their volumizing effect. HA-based gel fillers have been used for over 20 years for the augmentation of tissue volume. These fillers are injected below the surface of the skin to add volume, filling the lines, wrinkles, and folds, and hence, giving the skin a smoother appearance. One of the areas that suffers volume loss is the area over the cheekbones.2,3
Hyaluronic acid is a polysaccharide and a key molecule naturally present in the extracellular matrix with an important role in maintaining tissue structure and vascularity.4,5 Stylage XL (Laboratoires VIVACY, Paris, France) is a sterile HA gel, of nonanimal origin, manufactured using the patented “Inter-Penetrating Network-Like” (IPN-Like) cross-linking technology. Laboratoires VIVACY have marketed the HA-based product Stylage XL Lidocaine, a monophasic gel consisting of 1,4-butanediol diglycidyl ether (BDDE) cross-linked HA, intended for the restoration or augmentation of facial volume. This formulation includes lidocaine hydrochloride for the reduction of injection-associated pain. This postmarket clinical follow-up study was designed to evaluate the efficacy and safety of Stylage XL Lidocaine in the augmentation and/or restoration of facial volume.
This was a single-center prospective uncontrolled single blind study undertaken in an aesthetic center in France between November 2019 and July 2021.
