According to the International Society of Aesthetic Plastic Surgeons, a worldwide increase of 50.6% was observed for hyaluronic acid injections in the facial region in 2019 compared to 2015, while the number of performed facelifts increased by 9.0% in the same time-span. 1 The increasing demand for minimally invasive augmentations with hyaluronic acid-based fillers can be explained by the ease of the procedure resulting in a more harmonious and appealing facial appearance while patients do not have to face any downtime as experienced in surgical interventions. [2][3][4][5] Naturally, the effect of minimally invasive injections of hyaluronic acid is
Background: Minimally invasive treatments as soft tissue filler injections can enhance the appearance of the jawline. This prospective, single-center study investigated aesthetic outcome, patient satisfaction, adverse events, and volume changes after jawline contouring using standardized reporting scales and objectifiable 3D surface analysis.Methods: A total of 30 patients (1 male and 29 females, mean age: 57.2 (±8.7) years) were investigated. Patients underwent jawline augmentation using a highly crosslinked hyaluronic acid-based soft tissue filler. Three-dimensional surface imaging was performed after 2 weeks, and 3, 6, 9, and 12 months. Furthermore, the aesthetic results and the occurrence of complications were investigated after two weeks, and 3, 6, 9, and 12 months. Results:The surface-volume coefficient (SVC) had an average of 1.10 ± 0.2 after 14 days, 0.95 ± 0.1 after 3 months, 0.83 ± 0.1 after 6 months, 0.74 ± 0.1 after 9 months, and 0.63 ± 0.1 after 12 months. A significant correlation was revealed between time of measurement and measured SVC with r p = −0.761, p < 0.001. Multivariate analysis revealed a significant difference between the measured SVC and the different time points of measurement with p < 0.001. The data revealed strong aesthetic improvement with results most often reported as "very much improved" according to the 5-point GAIS after 3, 6, and 9 months, both by the investigator and by the patients. A 12-month follow-up analysis showed "much improved" results in a majority of cases. Conclusion:The result of this investigation showed that jawline enhancement using minimally invasive soft tissue filler injections produces durable, safe results that are generally rated as very satisfying from a patient's and investigator's perspective over a time period of 12 months.
Objective The aim of this investigation was to assess the effectiveness of a non‐cross‐linked hyaluronic acid based soft‐tissue filler in the correction of lateral canthal lines and periorbital lines. Material and methods A total of 59 female Caucasian patients with a mean age of 52.6 ± 9.0 years were enrolled in this prospective open‐label, multicentre study and received intradermal injections of a soft‐tissue filler at baseline, after 3 and 6 weeks. Aesthetic improvement and patient satisfaction, skin hydration, skin firmness and skin elasticity, as well as adverse events were assessed at 3, 6, 8, 12 and 16 weeks. Results At baseline, the lateral canthal skin firmness was 0.206 ± 0.07 mm and increased after 8 weeks to 0.087 ± 0.08 mm with p < 0.001, while the perioral skin firmness was 0.205 ± 0.09 mm and increased after 8 weeks to 0.116 ± 0.08 mm with p < 0.001. Increases in skin hydration were observed after 8 weeks in both areas, however, did not reach statistical significance at any point. At week 8, 12 and 16 a majority (93.1%, 91.1% and 73.7% respectively) of the patients stated that they were ‘satisfied’ or ‘very satisfied’ with the treatment. Conclusion Overall, the skin firmness and skin visco‐elasticity showed significant increases in the lateral canthal and perioral region. Moreover, albeit not statistically significant, skin hydration increased in both areas after 8 weeks. The procedure has been shown to be safe and satisfactory for the treated patients; however, emergence of oral herpes should be added to the safety profile of intradermally applied hyaluronic acid treatments.
PurposeNasolabial folds (NLFs) are one of the most noticeable signs of facial aging. NLFs negatively affect self-confidence and social acceptance often leading to a person’s desire to improve their appearance using dermal fillers. The hyaluronic acid injectable gel implant Princess® FILLER Lidocaine (PFL) is a minimally invasive easy to administer the product. In this investigation, we assessed the safety and efficacy of PFL to correct moderate to severe NLFs over a 36-week period.MethodsAdult women and men with moderate to severe NLFs received one injection of PFL to both NLFs. After 2 weeks, a touch-up treatment could be performed, if deemed necessary by the investigator. The change in NLF severity was assessed using the Nasolabial Fold Severity Rating Scale (NFL-SRS) developed by Croma-Pharma and the Global Aesthetic Improvement Scale (GAIS).ResultsOut of 60 analyzed subjects, 59 (98.3%) had improved their NLF severity by at least 1 grade on the NFL-SRS at week 4, 58 subjects (96.7%) at weeks 24 and 36. All subjects showed aesthetic improvement (GAIS), at weeks 4 and 24. The investigator judged the aesthetics as very much improved (score of 1) in 45 (75.0%) at week 4, 48 (80.0%) at week 24, and in 39 of 60 subjects, respectively (65.0%) at week 36. Thirty-six weeks post-initial treatment, 56 of 60 subjects (93.3%) were very satisfied or satisfied with the treatment. Adverse device effects (ADEs) were mild or moderate and resolved at latest 25 days post-onset. The most commonly reported ADEs were injection site hematoma and injection site pain.ConclusionPFL was safe and effective in reducing the severity of NLFs. Most subjects were (very) satisfied with the treatment outcome throughout a 36 weeks investigation period.
Background Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. Objectives This post-market investigation evaluated Princess Volume Plus Lidocaine (now Saypha Volume Plus Lidocaine) (PVPL) long-term performance, safety and patient satisfaction for the correction of midface-volume-deficit (MVD). Methods This was an open-label, prospective, interventional, multicenter, non-comparative, post-approval study of 91 subjects with moderate or severe MVD [grade 2 or 3 on the five-point Midface Volume Deficit Severity Scale (MVDSS)]. At Day 0 (Visit 1), subjects were treated with PVPL; and, returned for follow-up assessments at week 2, 4, 12, 24, 36, 52; and long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed using MVDSS, Global Aesthetic Improvement Scale (GAIS), and Subject Satisfaction Scale. Adverse events (AEs) were collected to assess safety throughout the study. Results 4-weeks after treatment, 100%-injected subjects improved by ≥1 grade on MVDSS compared to baseline, with improvements still visible in 77% of subjects 52-weeks after treatment. Based on GAIS and post-hoc survival analysis, the treatment effect was maintained for a median of 386 days; and, in severe cases the effect lasted longer, which seemed to be independent of the volume injected at baseline. No serious side effects were reported. Results were substantiated by high patient satisfaction. Conclusions Princess Volume Plus Lidocaine was perceived as safe and effective by subjects/investigators, with a long-term aesthetic improvement in moderate and severe cases.
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