Search

Background: Correction of cheek wrinkles using poly- l -lactic acid (PLLA-SCA) was demonstrated in a 12-month study., Objective: This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data., Methods: Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9., Results: The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% ( p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: -0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control., Conclusion: Poly- l -lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface., Clinical Trial Registry Number: NCT04124692., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

Non-facial (body) rejuvenation is a treatment of increasing demand, with patients seeking to harmonize the benefits of rejuvenated facial appearance with other areas of the body. Poly-L-lactic acid (PLLA)-SCA (Sculptra®) has been approved for facial aesthetic uses since 1999 in Europe and since 2009 in the USA and more recently evaluated for the treatment of cellulite of the buttocks and thighs and other body indications. The current evidence base consists largely of prospective observational analyses and case series although systematic evaluations for a number of body areas are underway. Current data support a potential benefit for the use of PLLA-SCA for the aesthetic treatment of the neck, knees, abdomen, hands and upper arms. Improvements in aesthetic appearance (e.g. sagging, wrinkling, dimpling, cellulite) that are sustained over time with minimal side effects can be achieved. Standardization of injection protocols for different body areas is now needed along with the validation of clinical tools that can be used to agree on treatment goals and to evaluate aesthetic improvements over time. A group of international experts in the fields of facial and body aesthetics, plastic surgery and dermatology were selected based on their educational, scientific and publication merits together with clinical experience using PLLA-SCA for body rejuvenation. Here, we provide an evidence-based and expert-led consensus (14 years of off-face treatment experience) on recommendations for appropriate injection protocols for different body sites and evaluation tools when using the biostimulator PLLA-SCA for body aesthetic and rejuvenation procedures.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 ., Competing Interests: Declarations. Conflict of interest: AH is a speaker, trainer, consultant and clinical trial investigator for Galderma. LA is a speaker, trainer, consultant and clinical trial investigator for Galderma. SGF is a consultant, investigator and speaker for Galderma, Allergan, Merz and Revance. JS is a speaker and advisor for Galderma. MSom is a speaker, trainer, clinical trial investigator, consultant for Galderma and Merz. DD’AC is a consultant, investigator and speaker for Galderma, Allergan and IBSA. MP has conducted research and/or served as an advisory board member, speaker, and/or trainer at Endo Aesthetics, BTL Industries, Allergan, Galderma, Merz Pharma, Lumenis, EltaMD, and Revision. KKD is a speaker, trainer, consultant, and investigator for Galderma. MS is a speaker and consultant for Galderma. RVB is a speaker, trainer, consultant and clinical trial investigator for Galderma. LH is a speaker, trainer, consultant for Galderma. KMB is a speaker, trainer, clinical investigator and consultant for Galderma. JH is a consultant and speaker for Galderma and a speaker for Merz. RF is a speaker, trainer and consultant for Galderma, and consultant for Allergan and Merz. DH is a speaker, consultant and researcher for Galderma and a speaker for Merz. CM is an employee of Galderma. FW is an employee of Galderma. IP is an employee of Galderma. DB is an employee of Galderma. Ethical Approval: This article does not contain any studies with human participants or animals performed by any of the authors. Informed Consent: For this type of study, informed consent is not required., (© 2024. The Author(s).)

Background: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced with PEARL (precipitation-free extraction and activity-preserving refined liquid) manufacturing technology, which yields a potent, complex-free formulation., Objectives: In the READY-1 study, efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction were examined., Methods: Adults with moderate to severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades improvement from baseline on concurrent investigator (glabellar line investigator live assessment; GL-ILA) and participant (glabellar line subject live assessment; GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for participants scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Participant satisfaction and treatment-emergent adverse events (TEAEs) were reported., Results: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, n = 199) vs 0% (placebo, n = 67; P < .001). Month 1 investigator-reported none or mild responder rate was 96.3% (RelaBoNT-A) vs 4.5% (placebo; P < .001). GL-ILA scores remained higher with RelaBoNT-A (23.6% [none or mild]; 58.1% [≥1-grade improvement]) vs placebo (1.5%; 10.4%, respectively) through Month 6 (P < .001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end of study). Participants reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild., Conclusions: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: Patients can have different reasons for seeking cheek augmentation; while some are in need of volume augmentation, others may request projection and lifting. A treatment guide can be useful for treating clinicians in choosing the most suitable product., Aims: This 8-week, multicenter study was conducted to evaluate the effectiveness and safety of cheek augmentation using a treatment guide to choose between study products HA CON and HA LYF ., Patients/methods: Female subjects intending to undergo cheek augmentation were treated according to primary need for treatment-HA CON for contouring or HA LYF for projection. Treatments were performed according to approved labels. Assessments included Global Aesthetic Improvement Scale (GAIS) evaluations, subject satisfaction, subject-perceived age (FACE-Q), naturalness of facial expressions, 3D imaging analysis, and safety assessments., Results: All subjects (n = 60) were assessed as aesthetically improved by the investigators 4 and 8 weeks after last injection. For all subjects, contouring or projection was achieved as planned with natural-looking results. Subject satisfaction was high in both study groups. Volume change of the cheek area was statistically significant from baseline to Week 4 (p < 0.001), in both treatment groups and on both sides of the face. Overall, treatments were well tolerated with mainly mild adverse events related to treatment., Conclusions: The proposed guide for product selection of HA CON or HA LYF for treatment of the cheek area was useful to achieve the primary treatment goal for both products. Treatments were well tolerated and associated with improved aesthetic appearance of the cheeks as well as high subject satisfaction., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Botulinum neurotoxin type A (BoNT-A) is well-established for treatment of glabellar lines (GLs), and mostly formulated as powders requiring reconstitution for injection. The approved liquid formulation, ready-to-use (RTU) abobotulinumtoxinA was developed to ease injection procedures and prevent reconstitution errors. This multicenter, open-label, Phase IV study evaluated GL treatment experience using RTU abobotulinumtoxinA versus powder BoNT-A (onabotulinumtoxinA)., Methods: Females with experience of BoNT-A facial treatment were randomized 2:1 to GL treatment with 50 U RTU abobotulinumtoxinA (N = 99) or 20 U powder BoNT-A (N = 51) and followed-up for 6 months or 1 month, respectively. Assessments included: time to prepare each product for injection (primary endpoint); investigators' experience with product preparation/reconstitution; investigators' and subjects' treatment experience; safety; and for the RTU product: aesthetic improvement of GLs; subject satisfaction., Results: Compared with powder BoNT-A, RTU abobotulinumtoxinA required statistically significantly less preparation time (mean 0:33 vs. 1:34 min: s; p < 0.0001). Investigators preferred RTU abobotulinumtoxinA over powder BoNT-A (81% of treatment sessions) and found it allowed more time to communicate with subjects (97%). All investigators (100%) also found it easy-to-use, easy-to-learn, and that it fulfilled their expectations. Subjects found the RTU abobotulinumtoxinA treatment comfortable (91%), and through 6 months posttreatment, most reported satisfaction with their appearance (≥88%), looking natural (≥95%) and refreshed (≥80%). At Month 1, 99% of RTU-treated subjects had investigator-assessed improved aesthetic appearance in GLs, maintained in 76% at Month 6. No serious adverse events occurred., Conclusion: RTU abobotulinumtoxinA for GL treatment is well-tolerated, efficacious, shows high levels of subject satisfaction throughout 6 months, saves time, and is preferred by clinicians over powder BoNT-A., Gov Registry: NCT05277337., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: AbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009., Objective: Pivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience., Materials and Methods: Patients seek an improvement in the appearance of their glabellar lines while maintaining a "natural look," fast onset of effect, and long duration of response., Results: Trial designs have evolved to meet these new targets, including expanding the definition of responders to those having at least 1-grade improvement in the glabellar line severity scale score from baseline coupled with the use of subject satisfaction and psychological well-being questionnaires., Conclusion: The findings demonstrate that abobotulinumtoxinA remains a well-tolerated and consistently effective treatment option associated with a rapid onset of effect, duration of efficacy lasting up to 6 months, and high, long-lasting levels of patient satisfaction., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.&nbsp; Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.&nbsp; Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P&lt;0.001) and maintained through month 12 (P&lt;0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported., Conclusions: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.&nbsp; &nbsp; &nbsp;doi:10.36849/JDD.8145.

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., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society.)

Background: The current study evaluated the effectiveness and safety of Sculptra&nbsp;injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control., Methods: Male/female immune-competent adults (aged &gt;21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12., Results: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P&lt;0.0001), and 12 (71.6% versus 26.1%; P&lt;0.0001). Treating investigators reported improvements in skin radiance (&gt;95%), tighter appearance (&gt;88%), and jawline contour (&gt;85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections., Conclusion: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments., Clinicaltrials: gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305.&nbsp; &nbsp; &nbsp; &nbsp; doi:10.36849/JDD.7729.

Background: With a wide range of hyaluronic acid (HA) filler products available, knowledge of gel characteristics is a key part of tailoring treatments to each patient's aesthetic goals. This paper presents 2 main gel characteristics - strength/firmness and flexibility - for HA fillers produced using NASHA&reg; and OBT&trade; and their clinical significance for tissue performance., Methods: Three NASHA gels (Restylane&reg;; Restylane Silk; Restylane Lyft) and 4 OBT gels (Restylane Refyne; Restylane Kysse; Restylane Volyme; Restylane Defyne) were studied in dynamic mode using a PP25 rheometric measuring system at 25 degrees C. Gel strength/firmness was measured using frequency sweep, with G prime evaluated at 0.1 Hz. Flexibility assessments used amplitude sweep measurements between 0.1% and 10,000% strain at 1 Hz, with xStrain being the strain value at the crossover point where G prime and G double prime have the same value.&nbsp; Results: Restylane, Restylane Silk, and Restylane Lyft had G primes of 701, 416, and 799 Pa, respectively. OBT G primes for Restylane Refyne, Restylane Kysse, Restylane Volyme, and Restylane Defyne were 70, 160, 171, and 271 Pa, respectively. The xStrain values were 1,442% (Restylane Refyne), 908% (Restylane Kysse), 930% (Restylane Volyme), 761% (Restylane Defyne), 7% (Restylane), 19% (Restylane Silk), and 17% (Restylane Lyft).&nbsp; Conclusions: OBT products had high flexibility (tolerance to deformation) and low to intermediate strength/firmness, which make them appropriate for dynamic facial areas. NASHA products showed greater strength/firmness, with the potential to create lift and projection. Altogether, NASHA and OBT HA gels covered a wide range of strength and flexibility. J Drugs Dermatol. 2024;23(1):1332-1336.&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.7648.

Background: Injectable poly-L-lactic acid (PLLA) has been proven safe and effective with numerous medical applications for more than 25 years. The product has been approved in over 40 countries and is being used for soft tissue augmentation in the face and certain body parts. With the increased demand for subtle and natural-looking aesthetic treatments in the Asia-Pacific region, there is also a heightened need for consistent preparation and effective treatment methodologies to optimize outcomes for Asian patients., Methods: The body of evidence in medical literature, clinical data of presented case reports, and the collective experience of the authors are reflected in these consensus recommendations, which also take under consideration the availability of biostimulators in the Asia-Pacific region., Results: The resulting consensus recommendations include patient selection and assessment, management of treatment expectations, appropriate preparation and storage, proper injection techniques and treatment plans, management of adverse effects, PLLA combination with other facial rejuvenation procedures, and other constructive considerations., Conclusions: In the above consensus recommendations, the authors shared their best practices in accordance with the updated preparation and treatment protocols of PLLA. These recommendations represent the clinical and real-world techniques utilized by authors in providing PLLA treatments for Asian patients., (© 2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: Various botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport ® )., Objectives: Assess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox ® ), for the treatment of Chinese patients with moderate/severe glabellar lines., Methods: Phase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2-5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2-5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity., Primary Endpoint: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator's live assessment [ILA] and subject's self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded., Results: Overall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment., Conclusions: After a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients., Level of Evidence I: 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 ., (© 2022. The Author(s).)

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., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

Background: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U)., Aims: Evaluation of subject-reported indicators of treatment efficacy, satisfaction, and psychological well-being with ABO dose escalation., Methods: A Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject-assessed improvement in line severity of ≥1-grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE-Q™ appraisal of lines, psychological well-being and age, and subject satisfaction., Results: The study included 399 subjects (88.2% were female). Respective responder rates (≥1-grade improvement) with ABO 50-125 U doses ranged between 96.3%-100% at Week 4, 65.0%-67.9% at Week 24, and 33.8%-44.4% at Week 36. GAIS responder rate and FACE-Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well-being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses., Conclusions: A single ABO treatment (dosed at 50-125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well-being., (© 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

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., (© 2021 The Aesthetic Society.)

Background: Botulinum neurotoxin type A has been used for the treatment of hyperhidrosis., Objective: To perform a systematic review of the literature to identify evidence on the treatment approaches and outcomes associated with abobotulinumtoxinA (aboBoNT-A) treatment of hyperhidrosis., Methods: EMBASE, MEDLINE, and the Cochrane Library were searched for relevant observational studies, randomized controlled trials, and nonrandomized controlled trials. There were no date or country restrictions. Bibliographies of review articles and recent congress proceedings (2017-2019) were also searched. Articles were screened using predefined eligibility criteria and relevant data were extracted., Results: Of 191 unique articles identified, 23 were considered relevant (3 observational studies, 10 nonrandomized controlled trials, and 10 randomized controlled trials). These articles provided data on axillary (13), palmar (7), and forehead (1) hyperhidrosis, compensatory hyperhidrosis of the back (1), Frey syndrome (1), and diabetic gustatory sweating (1). All studies reported that aboBoNT-A reduced sweating and no serious adverse events were observed. Patient satisfaction was high and improvements to quality of life were observed after aboBoNT-A treatment., Limitations: Variability in the injection technique when data were compared across studies., Conclusion: This study describes a range of treatment approaches and demonstrates positive outcomes of aboBoNT-A treatment for multiple types of hyperhidrosis., (Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

AbobotulinumtoxinA (aboBoNT-A) has been used for various cosmetic purposes, including minimization of moderate to severe lines, or other cosmetic indications, in the face and neck. We carried out a systematic review to identify all relevant evidence on the treatment approaches and outcomes of aboBoNT-A as a cosmetic treatment of the middle and lower areas of the face, and the neck. Embase, MEDLINE, Cochrane Library, congress proceedings and review bibliographies were searched for relevant studies. Identified articles were screened against pre-specified eligibility criteria. Of 560 unique articles identified, 10 were included for data extraction (three observational studies, 1 randomized controlled trial [with two articles] and five non-randomized trials). The articles provided data on gummy/asymmetric smile (2), marionette lines (5), masseter muscle volume (2), nasal wrinkles (2), perioral wrinkles (3) and the platysma muscle (4). All articles reporting on efficacy of aboBoNT-A demonstrated positive results, including reduction of wrinkles (5), reduction of masseter muscle (2) and degree of gummy smile (1) compared with before treatment. No serious adverse events were reported and patient satisfaction was high. In conclusion, positive findings support further research of aboBoNT-A for the middle and lower areas of the face, and in the neck, which are largely unapproved indications.

BACKGROUND: AbobotulinumtoxinA (AboBoNT-A; Dysport ® ; Ipsen, Boulogne-Billancourt, France/Azzalure ® ; Galderma, Lausanne, Switzerland) is a botulinum neurotoxin type A approved for aesthetic use in the treatment of glabellar lines in adult patients under 65 years in Europe, the United States, and other countries. OBJECTIVE: We sought to analyze current literature on patient satisfaction with aboBoNT-A for upper facial aesthetic indications. METHODS: A systematic review of literature databases (PubMed/MEDLINE, Embase, the Cochrane Library, and Google Scholar) was performed to identify English-language publications reporting on patients with aesthetic indications (including glabellar lines and wrinkles) receiving aboBoNT-A, that assessed patient and/or physician satisfaction with treatment, with no restrictions on comparator studies. Structured data extraction was used to enable inter-study analysis. A post-hoc analysis was also performed to assess patient satisfaction by sex and age, using results from the noninterventional APPEAL study of patients' satisfaction with aboBoNT-A for treating glabellar lines. RESULTS: Overall, 22 original research papers were identified. Patient satisfaction rates for aboBoNT-A treatment were significantly higher versus placebo from two weeks to between three and five months postinjection. At two to three weeks postinjection, patient satisfaction rates were 52% and 99% across studies. In studies with later time points, patient satisfaction rates were 85 to 87 percent at 5 months and between 25 and 100 percent at 6 months post-injection. Physician satisfaction was also high (97%-100%, across three treatments). No notable differences in patient satisfaction by sex or age were observed in the APPEAL study. CONCLUSION: High rates of patient satisfaction have been achieved with aboBoNT-A treatment for upper facial aesthetic indications. Despite the current recommended interval of ≥12 weeks, satisfaction with the aesthetic results of aboBoNT-A therapy is still evident up to 6 months post-injection in some patients., Competing Interests: FUNDING:This study was sponsored by Ipsen. DISCLOSURES:Dr. Smit has received consultant fees from Ipsen, Fillmed, Hansbiomed, and Inova Pharmaceuticals. Dr. Gubanova has received consultant fees from Merz, Ipsen, Galderma, and SkinCeuticals. Dr. Kaufman has received research grants from Allergan, Galderma, Merz, Revance and Evolus and consultancy fees from Allergan, Galderma, Merz, Revance, and Evolus. Dr. Landau has received consultant fees from Ipsen. Dr. Molina has received consultant fees from IBSA International. Dr. Andriopoulos is an employee of Galderma. Mr. Maisonobe and Dr. Prygova are employees of Ipsen. Dr. Redaelli has received constultant fees from Ipsen and FillMed and is the editor of Officina Editoriale Oltrarno Firenze., (Copyright © 2021. Matrix Medical Communications. All rights reserved.)

OBJECTIVE: We sought to analyze the current literature regarding time to onset and duration of effect of abobotulinumtoxinA (aboBoNT-A, Dysport®/Azzalure®) for upper facial aesthetic indications. METHODS: We conducted a systematic review of literature databases (PubMed/MEDLINE, Embase, Cochrane Library, and Google Scholar) to identify English-language publications relevant to: population (patients with aesthetic indications [including glabellar lines and wrinkles]); interventions (aboBoNT-A); comparators (no restrictions); outcomes (efficacy, including onset of action and duration of effect); and settings (clinical). A manual search of review paper bibliographies was performed. Structured data extraction was used to enable interstudy analysis. RESULTS: Overall, 42 original research papers relevant to aboBoNT-A onset and/or duration were identified. All 24 studies assessing efficacy within one week post-injection demonstrated some response at the first time point assessed, and all 37 studies assessing duration showed some response after 12 weeks. Although methodologies for assessing onset and duration differed, when outcomes were refined by reported mean/median, at least 50 percent of patients responding to treatment, or significance versus placebo or baseline at a given time point, onset was most often reported within 2 to 3 days (7 studies), and as early as 24 hours (2 studies). Duration was most often reported as four months (18 studies), although four studies provided evidence that aboBoNT-A efficacy was maintained at five months and three studies at or after six months post-injection. CONCLUSION: This review indicates that aboBoNT-A has a median onset of efficacy of 2 to 3 days and a longer duration of action (3-6 months across studies) than the current labelled minimum treatment interval (12 weeks)., Competing Interests: FUNDING:This study was sponsored by Ipsen. DISCLOSURES:Mark Nestor has served as investigator for and received research grants from Galderma, Allergan, and Evolus and received consultancy fees from Ipsen; Joel L. Cohen has received consultancy fees from Galderma, Allergan, Merz, Evolus, Revance, and CROMA; Marina Landau has received consultancy fees from Ipsen; Said Hilton has served as an investigator in clinical trials from Allergan, Ipsen, and Evolus; Andreas Nikolis has received consultancy fees and research grants from Galderma, Allergan, and Merz; Syed Haq is Director of Invictus Humanus Ltd, Chief Scientific & Medical Officer of Tarian Group Holdings Ltd, and has received consultancy fees from Galderma; Maurizio Viel has received consultancy fees from Ipsen; Bill Andriopoulos is an employee of Galderma; Inna Prygova is employed by Ipsen Pharma; Keith Foster and Philippe Picaut were employees of Ipsen at the time this research was conducted; Alessio Redaelli received consultancy fees from Ipsen and FillMed and is editor of Officina Editoriale Oltrarno Firenze., (Copyright © 2020. Matrix Medical Communications. All rights reserved.)

Background: Data on opinions and experiences of aesthetic medical procedures outside the United States and Western Europe are scarce., Aims: This study aimed to survey users and non-users of aesthetic procedures in countries where this information is less readily available, to understand attitudes and perceptions relating to beauty., Patients/methods: Two independent internet-based observational surveys were conducted. Survey 1: individuals from Colombia, Lebanon, Malaysia, Russia and Turkey who were 'users' or 'non-users' of aesthetic medical procedures. Survey 2: individuals from Colombia, Russia, Thailand, Turkey and the United Arab Emirates who were 'users' of non-surgical aesthetic treatments., Results: Surveys 1 and 2 were completed by 300 and 160 individuals, respectively, most of whom were female (94.0% and 99%). Overall, respondents rated the eyes and smile as the most pleasing male and female facial features. Most participants (mean 82.6%; range 75%-100%) believed maintaining a healthy lifestyle was important for ageing gracefully, and over one-third (36.0%; 28%-47%) believed men age more gracefully than women. The emphasis respondents placed on the importance of physical attributes vs inner feelings, internal beauty and self-confidence varied between countries. Users were often more positive about aesthetic medical procedure outcomes than non-users. Adequate information, good physician communication (including managing treatment expectations), treatment recommendations based on patient need and good aftercare improved treatment satisfaction., Conclusions: The eyes and smile were key features of attractiveness, but maintaining a healthy lifestyle was consistently considered an important factor for ageing gracefully. Ensuring patients are well informed was a major determinant of treatment satisfaction., (© 2020 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals, Inc.)

Background: Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport ® /Azzalure ® ) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting., Methods: APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3., Results: Of 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%)., Conclusions: In the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed., 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 . Trial registration NCT02353897.