Background Letibotulinumtoxin A (Croma Pharma GmbH, Leobendorf, Austria) is a newly manufactured neurotoxin derived from the C. botulinum strain CBFC26. Objectives To assess efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long term safety and efficacy following repeated injections. Methods In this prospective, randomized, parallel-group, double blind, multicentre, placebo – controlled phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections with 20 U of letibotulinumtoxin A or placebo. Glabellar line severity (GLS), onset and duration of effect, time to re-treatment and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and investigator) and an improvement ≥2 points in GLS score relative to baseline, at week 4 from baseline. Results At 4 weeks, 78.6% of the active treatment subjects where responders (reduction of ≥2 – points on the GLS and GLS of 0 or 1) based on the investigator assessment and 68.8% based on the subject assessment, resulting in a composite responder rate 64.7% for the active treatment group, while it was 0.0% in the placebo group (p < 0.001). The median time to onset of effect was 3.0 days. Time until first re-treatment for the letibotulinumtoxin A group was 127.26 ± 65.6 days. Letibotulinumtoxin A was well tolerated. Conclusions Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.
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 objective of this investigation was to create and validate 5‐point photonumeric scales for the assessment of dynamic crow's feet, static crow's feet, and infraorbital hollows. Material and methods Three novel 5‐point photonumeric scales were created by a medical team. A total of 12 raters from all over the world performed a digital validation, and a total of 5 raters a live validation of the created scale. Results The statistical analysis revealed almost perfect intra‐rater and inter‐rater reliability in the digital validation of the scales for the assessment of static and dynamic crow's feet as well as infraorbital hollows. In the live validation, both crow's feet scales showed almost perfect intra‐rater reliability, while the Croma Infraorbital Hollow Assessment Scale showed substantial intra‐rater reliability. Inter‐rater reliability was substantial for all three scales in the live validation. All three scales, the Croma Dynamic Crow's Feet Assessment Scale, Croma Static Crow's Feet Assessment Scale, and Croma Infraorbital Hollow Assessment Scale, were validated digitally and in a live setting. Conclusion The created scales to assess infraorbital hollowing, dynamic and static crow's feet have been shown to provide substantial to almost perfect agreement in the digital and live validation and can thus be considered as helpful tools in the clinical and research setting. While technical methods and appliances to assess the degrees of severity of age‐dependent features are advancing, validated scales are of great importance due to their ease of use and, as shown by the validations, reliability, and reproducibility.
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.
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