Creation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows.

BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.

Long-term efficacy and safety of a hyaluronic acid dermal filler based on Tri-Hyal technology on restoration of midface volume.

INTRODUCTION: Art Filler Volume (AFV) is a hyaluronic acid (HA)-based filler formulated with "Tri-Hyal" technology, a unique combination of three sizes of HA chains. This study assessed AFV efficacy and safety over 18 months when used to restore midface volume. METHODS: During this open-label study, a maximum of 1.8 mL AFV was injected into each cheek area on Day 0 (D0). Subjects were evaluated at D21, when, if necessary, a retouch could be performed (maximum 1.2 mL per cheek). Subjects were evaluated at seven follow-up visits through to D540. The primary assessment was based on the evolution of the Medicis Midface Volume Scale (MMVS) grade on D21. Secondary outcomes were local and general adverse events, investigator- and subject-assessed Global Aesthetic Improvement Scale scores and changes in self-esteem. RESULTS: Of the 79 healthy Caucasians enrolled (mean age 54.8 years), 25 required a second injection. In the intention-to-treat population, mean overall MMVS scores improved significantly from D0 (3.2 ± 0.4) to D21 (1.8 ± 0.6) and D42 (1.7 ± 0.6) (all p < 0.0001). MMVS scores for each cheek also improved significantly, irrespective of retouch on D21: 22% of injections showed a persistent benefit at D540 without retouch. The most common adverse events were pain on palpation (19%), erythema (15%) and edema (13%); most were mild or moderate and resolved within 2 weeks. CONCLUSION: AFV produces a sustained objective and subjective midface volume restoration in female and male subjects, often without retouching, and was well tolerated.

Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.

Purpose: Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). Patients and Methods: A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Results: Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. Conclusion: RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited. OBJECTIVES: The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. METHODS: Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. RESULTS: Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. CONCLUSIONS: The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population.

Midface Multilayering Filler Injection Technique: Understanding of the Dynamic Facial Anatomy Through a "Smiling Cadavers" Anatomical Study.

BACKGROUND: Understanding age-related changes in compartmentalized facial fat and their role in facial dynamics and aesthetics is essential to target filler injections for midface rejuvenation. METHODS: A novel anatomical approach ("smiling cadavers") was used to identify the main midface fat compartments involved during muscular contraction when smiling and their motion and behavior with and without filler injections. Based on these insights and the literature, a multilayering filler injection approach was developed to optimize midface rejuvenation by restoring fat volumes using rheologically different products injected into different fat compartments. RESULTS: Twenty-four hemifacial dissections confirmed the presence of two fat compartment layers, separated by the orbicularis oculi muscle in the horizontal plane and by the septa in the vertical plane, and revealed the anatomical effects of facial movement. The midface is composed of deep static fat compartments and a superficial dynamic adipose layer that follows the facial movements, creating a natural dynamic appearance. A proof-of-concept study involved 130 White patients (36 to 56 years; 91 percent women). After the procedure, 95 percent of patients and 98 percent of practitioners rated facial appearance as "improved" or "much/very much improved." No major complications were reported. CONCLUSIONS: The smiling cadavers method enhances understanding of dynamic facial anatomy by showing the superficial and deep fat compartments of the midface at rest and their motion during a procedure to represent a smile. The multilayered injection technique takes into account these anatomical findings to rejuvenate the midface, achieving a natural appearance at rest and during motion.

Creation and validation of a photonumeric scale for assessment of lip fullness.

BACKGROUND: Validated, objective clinical scales are needed to assess aesthetic improvement of the lips after augmentation with dermal fillers. OBJECTIVE: To develop a lip fullness rating scale and establish its reliability for grading subjects in clinical trials or routine practice, and sensitivity for detecting clinically meaningful changes. METHODS: The Teoxane Lip Fullness Scale (TLFS), a proprietary, 5-grade photonumeric scale, was developed by clinical experts based on real subject photographs and was validated through both photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreement for the TLFS was substantial to almost perfect. Mean intra-rater weighted Kappa score between the two rounds of photographic validation was 0.92, and inter-rater agreement was substantial with an ICC of 0.93 for the combined rounds. Average intra-rater weighted Kappa score and inter-rater ICC for the live validation were equally high, reaching 0.91 and 0.89 respectively. Additionally, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference on the scale in 90% and 98% of cases, respectively. CONCLUSIONS: The intra-rater Kappa scores and inter-rater ICC met their pre-determined acceptance criteria of >0.70 in the photographic and live validation. The TLFS was shown to be a repeatable and reproducible Clinician Reported Outcome (Clin-RO) for healthcare providers to classify lip fullness both in clinical trials and in routine patient care. A 1-grade difference on the TLFS can detect a clinically meaningful difference in lip fullness.

Injection Guidelines for Treating Midface Volume Deficiency With Hyaluronic Acid Fillers: The ATP Approach (Anatomy, Techniques, Products).

Midface rejuvenation is among the most valuable indications of hyaluronic acid dermal fillers, because malar projection and full upper cheeks significantly contribute to a youthful appearance. Hyaluronic acid fillers have evolved over the past 2 decades to meet specific clinical needs such as strong projection capacity and adaptability to facial dynamism. As a result, they now represent the treatment of choice for midface rejuvenation throughout age ranges by offering the potential for noninvasive treatment, immediate results, and minimal downtime. Because the 5-layered structure of the midface plays a central role in the human face, injecting the midface area may also indirectly improve other aesthetic concerns such as infraorbital hollowing and nasolabial folds. Nonetheless, midface rejuvenation requires a tailored treatment approach and a thorough knowledge of anatomy to minimize procedural risks and achieve natural-looking results. This article provides an extensive anatomical description of the midface and of the usual course and depth of vascular structures circulating nearby to delineate a treatment area and minimize procedural risks. Furthermore, considering the differential mobility and mechanical constraints of each layer of the midface, a multilayer treatment algorithm is proposed for adapting the treatment strategy to patient specificities (including age, gender, skin type, and morphology). Emphasis is also placed on desirable filler properties to create deep structural support on the one hand and accompany facial movement on the other hand.

Consensus Recommendations on the Use of Hyaluronic Acid-Based Fillers for Nonsurgical Nasal Augmentation in Asian Patients.

BACKGROUND: Nonsurgical nasal augmentation using dermal fillers such as hyaluronic acid is increasing in popularity because of its less invasive nature and shorter downtime compared with traditional surgery. However, the complexity of the nasal vasculature makes it a high-risk procedure without proper training. Appropriate patient and product selection and safer standardized injection techniques are warranted to minimize complications and to achieve reproducible aesthetic results. In this article, recommendations for nonsurgical nasal augmentation using hyaluronic acid fillers are outlined, with focus on the dorsum, tip, and columella. METHODS: A consensus meeting was conducted to develop recommendations on nonsurgical nasal augmentation in Asian patients using hyaluronic acid-based fillers. Literature review was performed using PubMed and Google Scholar. Relevant studies were included to formulate recommendations. Consensus statements were graded using the criteria outlined by the Grading of Recommendations Assessment, Development and Evaluation Working Group. RESULTS: Nonsurgical nasal augmentation is an advanced procedure that warrants in-depth knowledge of the nasal anatomy. The panel recommends thorough preinjection assessment and counseling to fully align the patient's expectations with aesthetic goals. Injections must be deep and at the level of the periosteum or perichondrium to minimize risk of intravascular injection. Aliquots of hyaluronic acid must be introduced using slow, low-pressure, and low-volume injections. Optimal aesthetic effect is achieved with hyaluronic acid dermal fillers that are highly elastic, cohesive, and with good adaptability to their environment. CONCLUSIONS: Hyaluronic acid injections are safe and effective in nonsurgical nasal augmentation. In-depth knowledge of vascular anatomy and proper injection techniques using suitable products are necessary to achieve aesthetic goals safely. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Advanced Concepts in Rheology for the Evaluation of Hyaluronic Acid-Based Soft Tissue Fillers.

BACKGROUND: Crosslinked hyaluronic acid (HA)-based soft tissue fillers possess unique viscoelastic properties intended to match specific product indications. Manufacturing has an impact on HA chain integrity and on filler properties. OBJECTIVE: This study introduces 2 new rheological parameters to evaluate the macroscopic characteristics of fillers. METHODS AND MATERIALS: A library of reference commercialized HA fillers was selected to cover the full spectrum of product indications. Gels were assessed in terms of size of released HA fragments as a readout of gel integrity, degree of modification, cohesivity, and rheological properties. RESULTS: The elastic modulus G' often used to characterize fillers was shown not to follow macroscopic mechanical properties. To improve the mechanical characterization of fillers, Strength and Stretch scores were developed and tested. The Strength score defined the ability of a filler to sustain constant viscoelasticity over a wide range of constraints and represented the filler mechanical resilience. The Stretch score measured the propensity of a filler to deform in view to improve implant adaptation to facial animation for natural-looking results. CONCLUSION: Strength and Stretch scores sorted rheological parameters to macroscopic cohesivity assays more accurately than G' and may thus help predict the gel behavior once implanted and submitted to facial dynamics.

Primary lymphedema French National Diagnosis and Care Protocol (PNDS; Protocole National de Diagnostic et de Soins).

Primary lymphedema is a rare chronic pathology associated with constitutional abnormalities of the lymphatic system. The objective of this French National Diagnosis and Care Protocol (Protocole National de Diagnostic et de Soins; PNDS), based on a critical literature review and multidisciplinary expert consensus, is to provide health professionals with an explanation of the optimal management and care of patients with primary lymphedema. This PNDS, written by consultants at the French National Referral Center for Primary Lymphedema, was published in 2019 ( https://has-sante.fr/upload/docs/application/pdf/2019-02/pnds_lymphoedeme_primaire_final_has.pdf ). Primary lymphedema can be isolated or syndromic (whose manifestations are more complex with a group of symptoms) and mainly affects the lower limbs, or, much more rarely, upper limbs or external genitalia. Women are more frequently affected than men, preferentially young. The diagnosis is clinical, associating mild or non-pitting edema and skin thickening, as confirmed by the Stemmer's sign (impossibility to pinch the skin on the dorsal side or the base of the second toe), which is pathognomonic of lymphedema. Limb lymphoscintigraphy is useful to confirm the diagnosis. Other causes of swelling or edema of the lower limbs must be ruled out, such as lipedema. The main acute lymphedema complication is cellulitis (erysipelas). Functional and psychological repercussions can be major, deteriorating the patient's quality of life. Treatment aims to prevent those complications, reduce the volume with low-stretch bandages, then stabilize it over the long term by exercises and wearing a compression garment. Patient education (or parents of a child) is essential to improve observance.

French Kiss Technique: An Anatomical Study and Description of a New Method for Safe Lip Eversion.

BACKGROUND: To minimize complications with injectable fillers, aesthetic practitioners need a detailed knowledge of facial anatomy. OBJECTIVE: To describe a novel approach ("subtractive anatomy") to identify locations where lip eversion using filler injections would be well tolerated and to evaluate the "French kiss technique" (FKT) to enhance the length of the lips using a low cohesivity hyaluronic acid filler. MATERIALS AND METHODS: Twenty hemifaces were dissected from 10 nonembalmed, nonfrozen Caucasian cadavers to assess subtractive anatomy. The FKT "proof-of-concept" evaluation enrolled 120 patients (114 women; mean age 42 years). RESULTS: The arterial supply of the lips shows marked anatomical variations between patients and when comparing sides of the face in the same person. The dissections revealed a "safe area" for filler injections in the submucosal plane 3 to 4 mm above the vermilion-mucosa junction of the upper lip and 3 to 5 mm below the vermilion-mucosa junction of the lower lip. Preliminary results suggest that FKT is associated with very good cosmetic outcomes and no major complications. CONCLUSION: Based on our anatomical studies and the literature, we developed the novel FKT for the injection of lip fillers, which produced a marked natural lip plumping effect. Further evaluation is underway.

Objective 18-month Comparison of the Tolerability of 2 Dermal Fillers Formulated with Tri-Hyal Technology.

The first phase of this study showed that ART FILLER Universal filler (AFU; FILORGA Laboratories) and ART FILLER Fine lines (AFFL) were non-inferior to JUVÉDERM Ultra 3 (Allergan) and FIRST LINES PureSense (Teoxane), respectively. The clinical benefits of AFU and AFFL on nasolabial folds and crow's feet persisted until at least Day 180. This article reports results from an open-label extension phase that assessed the tolerability and efficacy of AFU and AFFL for up to 18 months based on clinical evaluation and ultrasound high-frequency imaging. METHODS: Eligible subjects were enrolled at D180 and assessed on D270, D360, and D540. The primary outcome measured was local tolerability. Secondary outcomes measured included: proportion of subjects in whom the severity of nasolabial folds and crow's feet remained at least 1 point below the baseline measurement (Lemperle scale); general safety; Global Aesthetic Improvement Scale scores by subjects and investigators; wrinkle volumes; and skin thickness by high-frequency ultrasound. RESULTS: Adverse events were consistent with the product information and the initial study. No serious adverse events were recorded. In exploratory analyses, wrinkle correction with AFU and AFFL is sustained for at least 18 months: 48.4% and 98.3% of subjects respectively still showed at least a 1-point decrease in the mean Lemperle score compared with the baseline. The benefits were sustained irrespective of whether subjects received additional injections. Modifications in wrinkle volume and skin thickness at D540 were statistically significant compared with the baseline. CONCLUSION: AFU and AFFL were well tolerated and, in exploratory analyses, showed a sustained efficacy for at least 18 months.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

Surgical Denervation of Platysma Bands: A Novel Technique in Rhytidectomy.

Prominent platysma bands in the neck are one of the first signs of aging. There is increasing demand for surgical facial rejuvenation, including procedures to tighten skin and muscle in the neck; however, obtaining long-lasting results is a challenge. The aim of this study was to characterize the efficacy and safety of platysma muscle denervation for this indication. The authors performed surgical platysma denervation, involving selective cervical branch section simultaneously performed with rhytidectomy, in eight patients with unilateral facial paralysis (as a solution for visible platysma bands on the unaffected side of the face) and in one patient requiring aesthetic rhytidectomy (bilateral surgery). Patients were monitored for at least 3 months after surgery (in some cases, for up to 21 months). There were no major postoperative complications. Eight of the patients were unable to contract the platysma following surgery, leading to an improvement in the platysma band appearance. This study demonstrated the effectiveness and safety of the platysma denervation technique. Sectioning the cervical branch of the facial nerve provides a permanent solution to improve the cosmetic appearance of platysma bands and can be combined with rhytidectomy. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, IV.

Proposed Guide to Lip Treatment in Caucasian Women Using Objective and Measurable Parameters.

BACKGROUND: The lips are a focal point of the face; however, their aesthetic proportions and effect on perceived facial beauty remain poorly defined. Perioral aging is highly individual, with several distinct and often simultaneous processes contributing to changes in lip contour and surface. These processes can affect lip volume and length, shape, and the degree of vermilion inversion. OBJECTIVES: We aimed to develop a treatment guide for Caucasian women that combined a complete analysis of the lips (including the effects of aging) with consideration of the rheological characteristics of the products used to assist practitioners in tailoring rejuvenation treatment to individual patients. METHODS: We reviewed existing literature to analyze the parameters that make the lips of Caucasian women "attractive" and investigated the rheological characteristics of different hyaluronic fillers to provide guidance on the optimal treatment for each woman. RESULTS: Our numerical definition of the lips is based on 4 specific parameters: philtrum height, upper vermillion height, ratio between philtrum and upper vermillion height, and golden ratio between upper and lower vermillion height. In our opinion, conserving the length of hyaluronic acid chains results in dynamic fillers that may provide better results with lower risk of asymmetry compared with conventional products. CONCLUSIONS: This new classification and associated treatment guideline aims to allow accurate assessment and enable practitioners to customize treatment for individual patients.

Prospective, Split-Face, Randomized, Long-Term Blinded Objective Comparison of the Performance and Tolerability of Two New Hyaluronic Acid Fillers.

BACKGROUND: There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers. OBJECTIVE: To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet. MATERIALS AND METHODS: Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS). The severity of nasolabial folds and crow's feet was assessed by independent blinded evaluators using the Lemperle scale at baseline, day (D) 30/D45, D90, and D180. Tolerability, Global Aesthetic Improvement Scale (GAIS), wrinkle volumes, and skin thickness and density were also measured at D30/D45, D90, and D180. RESULTS: At D30 and D180 respectively, 61 and 57 patients were assessed. Scores for nasolabial folds and crow's feet showed statistically significant improvements at D30, D90, and D180. AFU and AFFL were noninferior to JUV and FLPS, respectively. Most patients showed GAIS improvements, maintained until at least D180 and significant increases of collagen synthesis in crow's feet and nasolabial folds. Treatments were well tolerated. CONCLUSION: AFU and AFFL are noninferior to comparators. The methodology used represents a novel approach to augment existing clinical assessment of HA fillers.

IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.

BACKGROUND: In clinical practice, different upper facial areas are commonly treated together. OBJECTIVE: To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period. MATERIALS AND METHODS: In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores. RESULTS: A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection. CONCLUSION: IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

Platysma Bands: Is a Change Needed in the Surgical Paradigm?

BACKGROUND: Platysma bands are one of the first signs of aging of the neck. Current theories suggest that these bands develop because of skin sagging followed by loss of muscle tone. Treatment strategies therefore aim to tighten skin and muscle. The aim of the present study was to demonstrate that platysma bands are caused by muscular activity during the aging process and are not secondary to skin sagging. This suggests a new approach to managing platysma bands. METHODS: The authors conducted a descriptive, prospective clinical study of 25 patients who presented with definitive, unilateral, facial palsy following otoneurosurgical treatment. The authors targeted their observations on anterior neck bands. Patients were followed for up to 10 years. RESULTS: Of the 25 patients, 76 percent had visible platysma bands on the healthy side, but not on the paralyzed side, of their face. Platysma bands were present on both sides in the 12 percent of patients who had a spastic form of facial paralysis. There was no worsening of the platysma band appearance in any patient. No ptosis of the neck skin on the paralyzed side was observed. CONCLUSIONS: This study demonstrated that platysma bands are not related to relaxation of the platysma and skin laxity, but are caused by activity of the platysma muscle. The skin follows the muscle. These observations support a change in surgical management of the aging neck, moving from tightening the skin to denervating the platysma muscle. Further studies need to fully characterize the efficacy and safety of platysma muscle denervation in this indication.

Midface: Clinical Anatomy and Regional Approaches with Injectable Fillers.

The clinical approach towards the midface is one of the most important interventions for practitioners when treating age-related changes of the face. Currently a plethora of procedures are used and presented. However, few of these approaches have been validated or passed review board assigned evaluations. Therefore, it is the aim of this work to establish a guideline manual for practitioners for a safe and effective mid-face treatment based on the most current concepts of facial anatomy. The latter is based on the 5-layered structural arrangement and its understanding is the key towards the favoured outcome and for minimizing complications.