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.

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.

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.

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.

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.

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.

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.

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).

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.

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From a Randomized, Double-Blind, Placebo-Controlled, Phase III Study.

BACKGROUND: Treating upper facial lines (UFL)-a combination of glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)-is a common aesthetic practice. OBJECTIVE: To provide the first placebo-controlled evidence of the efficacy and safety of incobotulinumtoxinA for UFL. METHODS: Healthy subjects (≥18 years) with moderate-to-severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contraction were randomized to incobotulinumtoxinA or placebo. For incobotulinumtoxinA, 54 to 64 U were administered (GFL, 20 U; HFL, 10-20 U; LPL, 24 U). Investigator-assessed MAS scores were evaluated for each area at maximum contraction on Day 30, both separately (responder = score of "none" [0] or "mild" [1]) and combined (UFL; sum score ≤3). Adverse events were recorded until 120 ± 7 days after treatment. RESULTS: Overall, 156 subjects were treated (incobotulinumtoxinA: 105; placebo: 51). On Day 30 at maximum contraction, a significant (p ≤ .0001) effect of incobotulinumtoxinA versus placebo for GFL (84.5% vs 0.0%, respectively), HFL (70.9% vs 2.1%), LPL (64.1% vs 2.1%), and UFL combination (55.3% vs 0.0%) was demonstrated for investigator-assessed "none" or "mild" scores. Two cases of mild eyelid ptosis occurred with incobotulinumtoxinA. CONCLUSION: IncobotulinumtoxinA demonstrated significant efficacy in treating GFL, HFL, and LPL separately and combined, as well as a good safety profile.

Evolution in technique: use of hyalurostructure for lips rejuvenation as an alternative to needle injection without troncular anesthesia.

PURPOSE: To enhance lips ageing rejuvenation with specific microcannula and hyaluronic acid. METHOD: Clinical review was conducted from December 2010 to December 2011 among 46 patients complaining of predictable changes on lips and perioral region such as deficiency in contour definition, volume and projection. Lips rejuvenation injections were made using the hyalurostructure technique. RESULTS: Forty-two patients (92%) with a 6-month follow-up were satisfied or very satisfied with the aesthetic results after the hyalurostructure of the lips and the perioral region rejuvenation. The use of the specially designed cannula led to fewer complications. We noticed 40 oedemas (87%) that appeared 24-48 h after the injection and seven patients (15.2%) with haematomas. We noted fewer surface irregularities and a better distribution of the product. Patients' records showed the procedure was painless. CONCLUSION: The hyalurostructure technique reduces the number of punctures compared to that of the conventional method. The microcannula's blunt tip reduces the risks of intravascular injection of the substance and of reach and disruption of the key structures like vessels and nerves. Results revealed that the hyalurostructure used for lips rejuvenation and helps to maintain a natural effect and avoids pain.

The Emervel French survey: a prospective real-practice descriptive study of 1,822 patients treated for facial rejuvenation with a new hyaluronic acid filler.

BACKGROUND: Emervel consists of a range of 5 hyaluronic acid (HA) fillers (Touch, Classic, Lips, Deep, and Volume), with a fixed HA concentration (20 mg/mL), and various degrees of cross-linking and calibration. OBJECTIVES: To describe the current use of Emervel fillers in France. METHODS: Prospective multicenter, cross-sectional, real-practice, descriptive survey, including 1,822 patients injected with Emervel fillers for face rejuvenation by 58 French physicians between September 2010 and July 2011. The injection modalities were left to the respective physician's discretion. RESULTS: The physicians were dermatologists (52.3%), surgeons (43.8%), or general practitioners (14.1%). Nasolabial folds (NLF) with a mean severity 2.4 were mainly injected with Emervel Deep (51.0%) and Emervel Classic (36.0%) (mean volume: 1.0 mL), and primarily with the linear retrograde (LR) technique (89.3%). Marionette lines (ML), with a mean severity 2.6 were mainly injected with Emervel Deep (52.5%) and Emervel Classic (34.6%) (mean volume: 0.8 mL), and mainly with the LR technique (79.5%). More than 90% of patients had scores of 0 or 1 for erythema, bruising, edema, and pain. No serious adverse events were reported up to 15 months after the injection. CONCLUSION: These data could contribute to upcoming international consensus on optimal injection modalities of the Emervel range of HA fillers.

Clinical equivalence of conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa): 2012 multidisciplinary French consensus in aesthetics.

Botulinum neurotoxins are the most popular non-surgical treatments for aesthetic indications, but there is uncertainty about whether certain formulations are comparable in efficacy and safety and can be substituted for one another by a simple one to one dose conversion ratio. An expert panel of French practitioners was convened to establish a consensus on the clinical equivalence in efficacy and safety of OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa). The consensus was divided into three sections incorporating a biological, bibliographic and clinical analysis of the two toxins. This included a review of the published data that have directly compared the two toxins for aesthetic indications and a survey of the panel's extensive clinical experience with the two toxins in terms of efficacy and safety. All panel members reviewed and endorsed the content of each section. Among this expert panel of French aesthetic physicians and biologists there was consensus that OnabotulinumtoxinA and IncobotulinumtoxinA are clinically equivalent in terms of efficacy and safety, and that a switch from one drug to the other can be made using a simple 1:1 conversion ratio.

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.

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.

Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months.

BACKGROUND: Full-face rejuvenation with dermal fillers in patients with multiple aesthetic indications is rarely studied. OBJECTIVE: To assess whether a new range of hyaluronic acid filler is suitable for full-face rejuvenation and to evaluate efficacy, safety, and patient satisfaction. MATERIALS AND METHODS: In this 6-month study, participants could receive five different fillers from the same range (HA(E) )for up to eight indications (periorbital lines, tear troughs, cheeks, cheek folds, nasolabial folds, upper lip lines, lips, and marionette lines). Outcomes included global aesthetic improvement, improvement in each indication, adverse events, local tolerability, and satisfaction. RESULTS: Seventy-seven participants with a mean age of 54.5 were enrolled; 48.1% had five or more indications treated. Mean total injection volume (baseline and touch-up) per participant was 6.7 mL. At month 6, 92.1% of participants remained at least improved over baseline, 79.7% of participants were satisfied or very satisfied with the durability of the results, and 63.0% of participants felt a lot or much better than before injection. No specific safety concerns were reported except expected injection site reactions. CONCLUSION: In participants with multiple indications, full-face rejuvenation using HA(E) provided effective, safe, satisfactory results.

Sustained efficacy and high patient satisfaction after cheek enhancement with a new hyaluronic acid dermal filler.

BACKGROUND: Increasing volume is an important part of facial rejuvenation since volume loss is common and typically age-related. HA E Volume is a moderately firm gel designed to be injected into the subcutaneous tissue for volume enhancement. OBJECTIVE: To assess the efficacy, patient satisfaction, and safety fo HA E Volume in patients with bilateral volume loss of the cheeks. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. Subjects received HA E in the cheeks at baseline, and a touch-up injection was optional three weeks later. Global aesthetic improvement, cheek thickness (caliper measurements),changes in volume using three-dimensional (3-D) photo analysis, adverse events and injection site reactions were evaluated at each visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after the last injection. RESULTS: Investigators evaluated the great majority of subjects as much or very much improved in terms of aesthetic improvement of their cheeks at week 3 and at mounts 3 and 6 (89.3%, 90.9%, and 76.4%, respectively). After six months, 65.8 percent of the correction achieved at week 3 (optimal correction) was maintained in terms of cheek thickness (caliper assessments), confirmed by 67.7 percent of the volume maintained based on 3-D volume analyses. The majority of subjects (92.1%) were satisfied or very satisfied with their aesthetic outcome. A good tolerability profile was observed. CONCLUSIONS: Treatment with HA E Volume in cheeks led to good aesthetic improvement, sustained results confirmed by caliper and 3-D volume assessments, and high subject satisfaction.

Perioral rejuvenation with a range of customized hyaluronic acid fillers: efficacy and safety over six months with a specific focus on the lips.

BACKGROUND: Injectable fillers are frequently used to restore volume and correct wrinkles in perioral region. However, evidence for perioral indications is scarce. OBJECTIVE: Assess the efficacy, patient satisfaction, and safety of new range of hyaluronic acid fillers (HA E) in perioral enhancement. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. At baseline, subjects could receive HA E Touch, HA E Classic, HA E Lips and HA E Deep for the treatments of lips, upper lip lines, nasolabial folds and marionette lines, and a touch-up infection was optional three weeks later. Lip Fullness Grading scale (for lips), wrinkle assessments (Lemperle Rating Scales for the remaining indications), adverse events, and local tolerance were evaluated at each visit, and 3-D volume analyses (for nasolabial folds and lips only) at each post-baseline visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after last infection. RESULTS: Overall, HA E Lips was infected for lip enhancement, HA E Thouch and HA E Classic for upper lip lines, and HA E Classic and HA E Deep for both nasolabial folds and marionette lines. After six month, around a 1-grade improvement persisted according to the lip fullness and wrinkle assessment scales. The long duration of effect was confirmed by 3-D analyses, with 62.7-71.4 percent of volumes obtained at week 3 (optimal correction) maintained after six months. The majority of subjects (from 80% for upper lip lines with HA E Classic to 94.8% for nasolabial folds with HA E Deep) were satisfied or very satisfied with their aesthetic outcome. All products were safe and well-tolerated. CONCLUSIONS: Perioral enhancement with HA E fillers led to sustained effect in terms of lip fullness, wrinkle and 3-D volume assessments, and high subject satisfaction.

Correction of tear troughs and periorbital lines with a range of customized hyaluronic acid fillers.

BACKGROUND: The periorbital region is a challenging area for injectable filler. Overcorrection and/or the use of unsuitable fillers may lead to unwanted results. As evidence for this region is limited, most physicians follow a trial and error approach. OBJECTIVE: Assess the efficacy, patient satisfaction, and safety of the HA E filler range in periorbital rejuvenation. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. Subjects could receive HA E Touch, HA E Classic, and HA E Deep for the treatment of tear troughs and periorbital lines at baseline, and an optional touch-up three weeks later. Global aesthetic improvement for both indications, periorbital wrinkle assessments (Lemperle Rating Scale), 3-D volume analysis (for tear troughs only), adverse events and injection site reactions were evaluated at each visit. A subject satisfaction questionnaire was performed three weeks after last injection. RESULTS: Overall, HA E Classic and Deep were infected for tear troughs, and HA E Touch for periorbital lines. Mean aesthetic improvement in tear troughs was 1.5-2 grades for both products at each post-baseline visit, and results of the clinical evaluation were confirmed by results of 3-D volume analysis. Improvements of periorbital lines in both aesthetic outcomes and wrinkle severity were around 1.5 grades at week 3, and close to 1 grade at month 6. The majority of subjects were satisfied or very satisfied with their aesthetic outcome. Treatments of both indications were safe and well-tolerated, with only mild and transient injection site reactions reported. CONCLUSIONS: This HA E filler range is suitable for rejuvenation of the periorbital region, which leads to safe results, long-lasting efficacy and high levels of patient satisfaction.

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.