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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. Level of Evidence: 1 [ABSTRACT FROM AUTHOR]

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 HACON and HALYF. Patients/Methods: Female subjects intending to undergo cheek augmentation were treated according to primary need for treatment—HACON for contouring or HALYF 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 HACON or HALYF 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. [ABSTRACT FROM AUTHOR]

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. Level of Evidence: 5 [ABSTRACT FROM AUTHOR]

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.Level Of Evidence:1: [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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: 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: 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.)