Facial Painting and 3D Stereophotogrammetric Analysis of Facial Dynamics: A Reliable Anatomical Educational Method.

(1) Background: Accurate knowledge of the dynamic anatomy of facial muscles is crucial for the use of functional and aesthetic botulinum toxin injections. We studied the reliability and relevance of facial painting as a pedagogic tool for the dynamic anatomy of facial muscles. (2) Methods: Different facial expressions were performed by a female model after a professional makeup artist applied makeup to the various facial muscles on her left hemiface. A 3D photograph was taken at the beginning and end of each movement using the VECTRA H2 Imaging System device. Cutaneous movements were visualized using displacement vectors. The correlation between the theoretical and dynamic positions of the makeup-muscle was assessed by two facial anatomy experts, thanks to a correlation scale. (3) Results: The overall average score for the 11 analyzed muscles or muscle groups was 3.36 out of 4, indicating a "strong" to "very strong" estimated correlation. There was a moderate agreement between Evaluator 1 and Evaluator 2 (ICC: 0.64; 95%CI: [0.244; 0.852]; p-value: 0.005). (4) Conclusions: The educational model with facial makeup provides an indirect but nonetheless precise and reliable representation of all facial muscles on the skin's surface. It is presented as a reliable and reproducible method, which exhibits great potential as a teaching tool.

International Consensus Recommendations on the Aesthetic Usage of Ready-to-Use AbobotulinumtoxinA (Alluzience).

Alluzience (abobotulinumtoxinA RTU; Ipsen, Paris, France and Galderma SA, Lausanne, Switzerland) is the first ready-to-use (RTU) botulinum toxin type A liquid solution approved for the treatment of glabellar lines in Europe. In this article, the authors provide consensus recommendations on the aesthetic usage of abobotulinumtoxinA RTU. Members of the International Board on Alluzience convened to develop consensus on the treatment of glabellar lines as well as other facial wrinkles based on their own extensive experience. Consensus recommendations were developed to provide practical guidelines for injection of abobotulinumtoxinA RTU. General guidance on proper assessment, treatment planning, and patient education is provided, as well as specific injection guidelines per indication. Indications covered include glabellar lines, crow's feet, horizontal forehead lines, lateral eyebrow lift, lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, drooping mouth corners, masseter hypertrophy, hollow cheek lines, dimpled chin, and platysmal bands. These guidelines provide a practical framework to support routine injection of facial muscles with Alluzience.

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.

Comparative clinical study for the efficacy and safety of two different hyaluronic acid-based fillers with Tri-Hyal versus Vycross technology: A long-term prospective randomized clinical trial.

BACKGROUND: Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner. METHODS: In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded. RESULTS: The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.

Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment.

BACKGROUND: AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections. OBJECTIVE: To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies. METHODS: Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events. RESULTS: One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate. CONCLUSION: Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated.

Liquid Spreader Grafts: Internal Nasal Valve Opening with Hyaluronic Acid.

BACKGROUND: Nasal valve disorders frequently give rise to nasal obstruction. Dermal fillers could be used in the internal valve area to generate valve widening. The goal of this study was to report our "liquid spreader" procedure consisting in the injection of hyaluronic acid (HA) at the internal nasal valve in patients complaining of nasal obstruction. METHODS: The procedure described in this paper is suitable for patients with unilateral or bilateral nasal obstruction related to architectural features resulting in narrowing of the internal nasal valve. HA is injected along the internal valve from a single entry point located at the anterior part of the internal valve, thus creating a volume which will induce nasal valve widening. Rhinomanometries and visual analog scales (VAS) regarding nasal obstruction were collected before and after the procedure. RESULTS: Sixteen patients were enrolled (7 females). Mean age was 44 years (min=24 y-o, max=65 y-o). Thirteen presented nasal valve narrowing without septal deviation while 3 patients had high septal deviation. Before injection, mean nasal resistances were 3.4±5.6 sPa/mL (min=0.55, max=19.8). One month after injection, mean nasal resistances were 0.38±0.26 sPa/mL (min = 0.20, max = 0.85). The difference was statistically significant (p=0.049). VAS scores were improved with a trend back to baseline after 12 months. CONCLUSIONS: The liquid spreader is a useful procedure that can be combined with non-surgical esthetic rhinoplasties. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Safe Nonsurgical Rhinoplasty Procedure.

SUMMARY: Nonsurgical rhinoplasty procedures are not without risks: although rare, intravascular injections of hyaluronic acid can lead to serious complications. Very few authors have reported using cannulas for filler injection in the nose. The purpose of this article is to describe how the authors perform nonsurgical rhinoplasty using a single entry point and cannulas, significantly reducing vascular and infection risks. The procedure described in this article can be applied to all indications of nonsurgical rhinoplasty. The key point of the authors' procedure is the definition of a single, medial entry point. Using a 5-cm, 25-gauge, dome-shaped cannula, all nasal regions can be reached, from the anterior nasal spine to the nasion. The authors' nonsurgical rhinoplasty procedure using cannulas reduces complications and provides results similar to those achieved with needles.

Botulinum toxin type A for the treatment of excessive gingival display - A systematic review.

Gummy smile has traditionally been treated with invasive or demanding surgical and orthodontic techniques. Several studies have shown that targeted injection of the upper lip elevator muscles with botulinum toxin is an effective treatment for this condition. However, no standardized injection protocol with reproducible results has yet been published. A systematic review of the literature has been performed using Medline, Scopus, and Embase. All articles relevant to the research question were analyzed. After removing duplicates, 162 articles were selected, of which 9 were included in the analysis after applying exclusion and inclusion criteria, for a total of 269 patients. Onabotulinum toxin type A (ONA-BoNTA) was used in 7 studies and abobotulinum toxin type A (ABO- BoNTA) in 2 studies, at various dilutions. The number of sites injected varied from 1 to 3 per side, with variable targeting of the Levator labii superioris alaeque nasalis, Levator labii superioris, Zygomaticus minor, Zygomaticus major and Orbicularis oris. The dose used per side varied from 1.25 to 6 U of ONA-BoNTA and from 2.5 to 7.5 U of ABO- BoNTA. The injection protocol was tailored to the type of gingival smile in one study only, another study compared results of targeting two different muscles, and one study evaluated different dosages of toxin for the same injection site. The average improvement ranged from 24.85% to 99.65% and the effect persisted from 12 to 36 weeks. Very good patient satisfaction was reported in 6 studies. Fourteen adverse events were reported, all of them mild and transient. The treatment of gummy smile by botulinum toxin injection is effective, safe, rapid, minimally invasive and reversible. Protocols vary widely in the literature and no standardized procedure emerges. A patient-specific approach, adapted to their anatomy, type of gummy smile and the severity of the exposure seems to be the most appropriate. Randomized controlled studies are needed to make this approach more systematic.

Long-term Efficacy and Safety of Liquid AbobotulinumtoxinA Formulation for Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Randomized, Placebo-Controlled and Open-Label Study.

BACKGROUND: A ready-to-use liquid formulation of abobotulinumtoxinA (aboBoNT-A solution) has been developed. OBJECTIVES: The aim of this study was to assess the long-term efficacy and safety of aboBoNT-A solution for the treatment of glabellar lines. METHODS: This was a multicenter, multinational, Phase III study (NCT02493946), with randomized double-blind placebo-controlled (DBPC; 2:1 aboBoNT-A solution 50 U/placebo) and open-label (4 cycles aboBoNT-A solution) periods; additional patients were recruited into the open-label period. Patients were 18 to 65 years old, BoNT-naïve, and dissatisfied/very dissatisfied with moderate/severe glabellar lines at maximum frown. Investigator's live assessment (primary endpoint)/subject's self-assessment of glabellar line severity at maximum frown, patient satisfaction with glabellar line appearance, and FACE-Q patient-reported scales (facial appearance overall, psychological well-being, aging) were assessed. Adverse events were monitored. Analyses were performed on DBPC and long-term analysis (LTA; all patients receiving ≥1 aboBoNT-A solution injection) populations. RESULTS: Responder rates for the investigator's live assessment, the subject's self-assessment, and patient satisfaction were consistent at Day 29 postinjection across repeat LTA cycles (82.2%-87.8%, 62.8%-80.6%, and 72.2%-87.8%, respectively), with statistically significantly higher responder rates vs placebo (DBPC cycle: 81.6% vs 0.8%, 68.1% vs 2.3%, and 83.1% vs 5.7%, respectively; all P < 0.0001). Consistent improvements on FACE-Q scales occurred with repeat cycles (DBPC cycle: aboBoNT-A solution vs placebo, P < 0.0001). No new or unexpected adverse events, or neutralizing antibodies, were observed. CONCLUSIONS: These results support the long-term efficacy and safety of aboBoNT-A solution, and its superiority over placebo, for treatment of glabellar lines in adults.

Management of vascular complications following facial hyaluronic acid injection: High-dose hyaluronidase protocol: A technical note.

Aesthetic medicine has experienced major developments in recent years, which is illustrated by the increasing number of hyaluronic acid injected in the area of facial rejuvenation. Although considered low risk, it can rarely result in arterial embolization with potentially major aesthetic and functional consequences. These vascular complications range from livedo to skin necrosis to permanent blindness. In such cases the management is urgent. Early care leads to a successful recovery but most of the time the diagnosis is delayed. Several treatments have been suggested and the use of hyaluronidase is decisive. There is no official guideline on the use of hyaluronidase. The aim of this article is to propose a protocol to clarify the management of vascular complications of HA with high doses of hyaluronidase based on the literature and our clinical experience of 35 patients treated.

European Multicenter Prospective Study Evaluating Long-Term Safety and Efficacy of the Polycaprolactone-Based Dermal Filler in Nasolabial Fold Correction.

BACKGROUND: Age-related changes affecting facial areas can be corrected using minimally invasive dermal fillers. The use of polycaprolactone-dermal filler (PCL-filler) in aesthetics is increasing. OBJECTIVE: To evaluate the long-term safety and efficacy of the PCL-filler, in a European, multicenter, prospective study. MATERIALS AND METHODS: Subjects (n = 90) with moderate/severe nasolabial folds (Wrinkle Severity Rating Scale [WSRS]: 3 to 4) were treated on Day 0 with a single injection of similar volume on each side; safety and efficacy assessments were performed over an 18-month period. In 1 of the 3 study centers, safety was evaluated at 30 months. RESULTS: At Month 12 (M12; primary endpoint), 84% of subjects showed a ≥1-point improvement on the WSRS (M6: 92%; M18: 64%). From the investigator/subject's evaluation, from Day 7 to M12, Global Aesthetic Improvement was reported for >90% of subjects, with the effect maintained for up to 18 months in >80% of patients. Subjects/investigators reported high satisfaction and skin quality improvement. Most of the immediate injection-site reactions disappeared after 2 to 4 days. No severe or unexpected adverse events were reported. CONCLUSION: This study demonstrated the long-term safety and efficacy of the PCL-filler, with safety confirmed for up to 30 months.

A hyaluronic acid-based filler reduces lipolysis in human mature adipocytes and maintains adherence and lipid accumulation of long-term differentiated human preadipocytes.

The beneficial role of subcutaneous adipose tissue in skin rejuvenation derived from its capacity to fill the under-layer volumes but also from its ability to regulate the extracellular matrix production by dermis fibroblasts. Hyaluronic acid (HA), a major component of the extracellular matrix, is a commonly used injectable dermal filler showing excellent efficiencies to maintain tissue augmentation even after its biodegradation. To improve their stability, the HA molecules can also be "cross-linked" to each other. The effects of cross-linked HA-based fillers on the dermal structure are well known. For safety reasons, most of the physicians prefer to use the blunt cannula for injections. However, evidences showed that the cannula could not be located in the dermis, but it passes through immediate hypodermis and the long-lasting effect of cross-linked HA-based fillers may be related to its effects on adipose tissue. To test whether cross-linked HA has a direct effect on human adipocytes, we treated isolated adipocytes and precursors cells from human skin donors with cross-linked HA. Biochemical and cellular analysis demonstrated that treatment by cross-linked HA showed beneficial effects on differentiated cell adherence and survival as well as reduced basal and induced lipolysis in fully mature adipocytes. Taken together, these data showed that cross-linked HA promoted cell adherence and preserved the adipogenic capacity of preadipocytes during prolonged cell culture, bringing additional evidences of the beneficial role of cross-linked HA-based fillers in maintenance of the subcutaneous fat mass. This first study could defend a preventive approach to facial volume loss during natural aging.

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.

BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. OBJECTIVES: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. METHODS: This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. RESULTS: Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: "how rested your face looks" (P < 0.0001-0.0415), "I feel okay about myself" (P = 0.0011-0.0399), and "I feel attractive" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively). CONCLUSIONS: Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.

Liquid Formulation of AbobotulinumtoxinA: A 6-Month, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of a Single Treatment, Ready-to-Use Toxin for Moderate-to-Severe Glabellar Lines.

BACKGROUND: Safety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection. OBJECTIVES: The authors sought to assess 6-month efficacy, safety, and patient satisfaction of new ready-to-use abobotulinumtoxinA solution for injection (ASI) in patients with moderate-to-severe GL at maximum frown. METHODS: The authors conducted a phase 3, double-blind, randomized, placebo-controlled trial (NCT02353871). Patients (N = 185) were randomized (2:1) to receive ASI 50 U or placebo. GL severity was evaluated at days 8, 15, 29, 57, 85, 113, 148, and 183 employing a 4-point scale for investigator's live assessment (ILA) and subject's self-assessment (SSA). Primary endpoint was ILA of GL at maximum frown at day 29, and secondary endpoints were ILA and SSA of GL at maximum frown (all time points), patient satisfaction with GL appearance, time to onset, and duration of action. RESULTS: Responder rates were significantly higher for ASI vs placebo (88.3% vs 1.4%; P < 0.0001) at day 29 by ILA and all time points by ILA (P < 0.0001-0.0441) and SSA (P < 0.0001-0.0036). Sixty percent of patients reported onset of treatment response on or before day 3 (P < 0.0001 vs placebo), and in 5% of patients, efficacy by ILA lasted 6 months (day 183; P = 0.0441 vs placebo). Patient satisfaction rates were significantly higher for ASI vs placebo at all visits (P < 0.0001). Safety was comparable with the known abobotulinumtoxinA profile. CONCLUSIONS: ASI was significantly efficacious for improving moderate or severe GL vs placebo by investigator and patient assessment. ASI was associated with high patient satisfaction, a long duration of action, and comparable safety profile to abobotulinumtoxinA.

Repeated Full-Face Aesthetic Combination Treatment With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin-Boosting Hyaluronic Acid After Monotherapy With AbobotulinumtoxinA or Hyaluronic Acid Filler.

BACKGROUND: Full-face aesthetic treatment involving several treatment modalities may improve facial aesthetic outcome. OBJECTIVE: To evaluate clinical outcomes and patient perceptions of monotherapy with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by full-face combination treatments of ABO, HA filler, and skin-boosting HA (RSB). MATERIALS AND METHODS: Subjects aged 35 to 50 years were randomized to monotherapy with 50 s.U ABO in the glabella or ≤1 mL HA filler in the nasolabial folds (NLFs)/cheeks. At Month 6 and Month 12, all subjects received combination treatment with ≤50 s.U ABO in the glabella, ≤2 mL HA filler in the NLFs/cheeks (and other facial areas as applicable), and ≤1 mL RSB (additional RSB treatment at Month 7). Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events. RESULTS: Repeated full-face combination treatment with ABO, HA filler, and RSB was associated with considerably higher levels of aesthetic improvement and subject satisfaction than monotherapy with ABO or HA filler. Improvement rate of glabellar lines was increasing with each treatment. CONCLUSION: Repeated combination treatment achieved greater change in global facial aesthetic appearance than monotherapy. Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated.

Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid

Background: It is important to study full-face aesthetic combination treatments to establish well-founded individual treatment plans. Objective: To evaluate clinical outcome and perception of treatment with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by repeated combined treatment with ABO, HA filler, and Restylane® Skinboosters (RSB). Methods & Materials: This study was conducted at four sites in Sweden, France, and Brazil and included subjects aged 35-50 years with mild/moderate nasolabial folds and moderate/severe upper facial lines. Monotherapy was ≤125 s.U ABO in at least two upper facial indications with optional touch-up or ≤1 mL HA filler in nasolabial folds/cheeks. At months 6 and 12, both cohorts received ≤125 s.U. ABO in upper facial lines with optional touch-up, ≤2 mL HA filler in nasolabial folds/cheeks (and other facial areas as applicable), and ≤1 mL RSB. Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events. Results: Repeated full-face treatment with ABO, HA filler, and RSB was associated with better aesthetic outcome and higher levels of satisfaction than treatment with ABO or HA filler alone. However, even modest volumes of HA filler achieved good aesthetic outcomes and high satisfaction. Treatment of several indications was well tolerated. Conclusion: Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated. These data may be used as support when establishing individual treatment plans. J Drugs Dermatol. 2019;18(7):682-689.

Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment of Upper Facial Lines.

BACKGROUND: Botulinum toxins are the treatment of choice for wrinkles in the upper third of the face. OBJECTIVE: The purpose of this study was to evaluate the efficacy, safety, and subject satisfaction of abobotulinumtoxinA (ABO) for treatment of upper facial lines. MATERIALS AND METHODS: Subjects aged 35 to 50 years with moderate-to-severe upper facial lines were included in this study. Subjects received a maximum of 125 s.U. ABO in at least 2 indications with optional touch-up after 2 weeks. Assessments included wrinkle severity, global aesthetic improvement, subject satisfaction, and adverse events (AEs) 1, 3, and 6 months after treatment. RESULTS: At Month 1, 100, 94, and 93% of subjects were responders in dynamic glabellar, lateral canthal, and forehead lines, respectively. All subjects were improved 1 month after treatment, and the majority of the subjects were still improved after 6 months. After treatment, most subjects were satisfied with the appearance of their face, felt better about themselves, and agreed that the treatment made them look the way they feel. Seven subjects (22%) had 8 ABO-related AEs (mild-moderate); headache was most commonly reported (9%). CONCLUSION: AbobotulinumtoxinA effectively treated upper facial lines, with high patient satisfaction. Treatment was generally well-tolerated.

Liquid Formulation of AbobotulinumtoxinA Exhibits a Favorable Efficacy and Safety Profile in Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trial.

BACKGROUND: In most countries, approved botulinum toxin type A formulations require reconstitution before injection. OBJECTIVES: To evaluate the efficacy and safety of a ready-to-use liquid formulation of abobotulinumtoxinA (abobotulinumtoxinA solution for injection, ASI) in subjects with moderate to severe glabellar lines (GL). METHODS: In this Phase II, double-blind, placebo-controlled, randomized study, 176 female subjects (aged 30 to 60 years) were randomized into five treatment groups: ASI 20, 50, or 75 U, reconstituted abobotulinumtoxinA (aboBoNT-A) 50 U, and placebo. GL severity was assessed at maximum frown using a 4-point grading scale. Responders were subjects with severity grade of moderate [2] or severe [3] at baseline improving to none [0] or mild [1], evaluated at each time-point by Investigator's Live Assessment (ILA) or Subject's Self-Assessment (SSA). Safety profiles were also determined. RESULTS: Baseline characteristics were similar across groups. Responder rates on Day 29 by ILA were significantly greater for ASI 20, 50, and 75 U versus placebo (88.9%, 91.4%, and 87.9% vs. 0%, respectively; P < 0.0001). Similar results were observed by SSA. A greater proportion of responders was observed in ASI groups vs placebo from Day 8 to 113 for ILA and SSA (P < 0.001). AboBoNT-A responder rate on Day 29 for ILA was 77.1% (P < 0.1006 vs ASI 50 U); with comparable results by SSA. The ASI safety profile was comparable to that of aboBoNT-A. CONCLUSIONS: Ready-to-use liquid formulation of abobotulinumtoxinA was shown to be efficacious, with comparable results to reconstituted abobotulinumtoxinA, and to have a favorable safety profile in subjects with severe to moderate GL.