Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study.

BACKGROUND: Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. OBJECTIVES: This postmarket investigation evaluated the long-term performance and safety of and patient satisfaction with Princess VOLUME PLUS Lidocaine (PVPL; now Saypha VOLUME PLUS Lidocaine) for the correction of midface volume deficit (MVD). METHODS: This was an open-label, prospective, interventional, multicenter, noncomparative, postapproval study of 91 patients with moderate or severe MVD (grade 2 or 3 on the 5-point Midface Volume Deficit Severity Scale, or MVDSS). At Day 0 (Visit 1), patients were treated with PVPL; they returned for follow-up assessments at weeks 2, 4, 12, 24, 36, and 52 and had long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed with the MVDSS, Global Aesthetic Improvement Scale (GAIS), and a subject satisfaction scale. Adverse events were collected to assess safety throughout the study. RESULTS: Four weeks after treatment, 100% of injected patients improved by ≥1 grade on the MVDSS compared to baseline, with improvements still visible in 77% of patients 52 weeks after treatment. Based on the 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 patients and investigators, with long-term aesthetic improvement in moderate and severe cases.

An open-label, 4-week, prospective clinical study evaluating the efficacy and safety of a novel targeted skin care line addressing five common skin conditions.

BACKGROUND: Common skin conditions, such as irritated, dry, aging, and oily skin or dark eye circles with periorbital edema, usually do not require pharmaceutical therapy in form of dermatological drugs. They can, however, still affect the quality of life significantly. With the advent of newer cosmetics, a more targeted treatment of these dermatological conditions has become available to the public. There are few clinical studies investigating the efficacy and safety of cosmetics, leaving consumers exposed to potentially false claims of the cosmetic industry. This study aims to assess the efficacy and safety of a novel skin care series addressing the aforementioned five common skin conditions. METHODS: This open-label, single-center, 4-week, prospective clinical study evaluated the efficacy and safety of five novel skin care formulations, each targeting one of five common skin issues in 176 study subjects. The primary endpoint parameters for the change in irritated skin, dark and puffy eyes, dry skin, aging skin, and oily skin were assessed through validated questionnaires, scales, and biomedical devices. RESULTS: After 4 weeks of topical application of each formulation of a new targeted skin care, a significant improvement in all primary endpoints was detected. No undesirable effects occurred during this study. CONCLUSION: This study showed a significant improvement in five common dermatological conditions with a novel targeted skin care series. Moreover, this study leads the way for an overdue critical assessment and certification of cosmetic product claims.

A prospective open-label, multicentre study evaluating a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal and perioral lines.

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.

Longevity and subject-reported satisfaction after minimally invasive jawline contouring.

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 cross-linked 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 rp  = -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.

Volumization of the young and the old temple using a highly cross-linked HA filler.

BACKGROUND: A plethora of age-related changes contribute to hollowing of the temples, as bone remodeling, atrophy of the temporalis muscle, thinning of the skin, and deflation of the subcutaneous and deep temporal fat create the appearance of a skeletonized face. In addition, previous studies have established a relationship between facial skeletonization, temporal hollowing, and postmenopausal sarcopenia. OBJECTIVE: To compare the volume change, adverse events, and patient satisfaction of soft-tissue filler injections in the temple between young (<51) and old (>51) females. MATERIAL AND METHODS: A total of 30 women with a mean age of 53.1 ± 12.1 years underwent bilateral temporal volumization. Adverse events and satisfaction were assessed after 3 and 6 months. 3-Dimensional surface imaging was performed at baseline and after 2 weeks, 3 and 6 months to assess volumetric changes. RESULTS: A mean volume of 5.55 ± 1.9 cc was injected into the temples. A total of 31 adverse events were observed in 13 patients. The overall satisfaction of the procedure was very high after 3 and 6 months in both patient groups, and raters showed a significant agreement in their assessment of the aesthetic improvement, while the self-reported patient satisfaction was also substantially high. The surface-volume coefficient differed significantly between 14 days and 3 months post-injection only in pre-menopausal patients, while no significant difference was detected between 3 and 6 months. CONCLUSION: Temporal soft-tissue filler injections are safe and provide long-lasting aesthetic improvement both in pre- and postmenopausal women.

Safety And Efficacy Of Princess® FILLER Lidocaine In The Correction Of Nasolabial Folds.

PURPOSE: Nasolabial 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. METHODS: Adult 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). RESULTS: Out 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. CONCLUSION: PFL 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.