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Balanced Restoration: Optimizing Midface Rejuvenation Using Hyaluronic Acid Fillers.
Currently available hyaluronic acid filler technologies concentrate on reflation of the aging midface primarily with the use of fillers to reinflate the deep fat compartments. However, filler technology has evolved, which allows us to recon…
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DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia: Clinical Insights from a Real-World Early Experience Program.
[BACKGROUND] DaxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin (BoNT) formulated with a custom-engineered peptide, was recently approved for treating cervical dystonia (CD). DAXI demonstrated a long duration of symptom relie…
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Efficacy Remaining at Time of Requested Re-Treatment for Cervical Dystonia: A Potential New Treatment Paradigm with DaxibotulinumtoxinA.
The therapeutic efficacy remaining from prior treatments with botulinum toxins (BoNTs) when cervical dystonia (CD) patients prefer to be re-treated has not been well characterized. Here, we assessed the residual therapeutic efficacy of BoNT…
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Reply to Trosch et al. Comment on "Dashtipour et al. Dysphagia and Muscle Weakness Secondary to Botulinum Toxin Type A Treatment of Cervical Dystonia: A Drug Class Analysis of Prescribing Information. 2024, , 442".
We thank Trosch et al [...].…
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Efficacy and safety of DaxibotulinumtoxinA for injection in adults with cervical dystonia: Pooled global analysis of ASPEN-1 and ASPEN-1-CN randomized trials.
[BACKGROUND] DaxibotulinumtoxinA for injection (DAXI), the first long-acting botulinum toxin (BoNT) type A, is FDA approved for cervical dystonia (CD). DAXI's novel formulation, which includes a custom-engineered peptide, is designed to pro…
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A novel peptide excipient stabilizes DaxibotulinumtoxinA.
Surface adsorption of proteins in bulk drug product formulations and loss of protein structural integrity during manufacturing processes can diminish drug potency. In formulations containing low biologic drug substance, such as botulinum to…
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Optimized Aesthetic Outcomes When Treating Glabellar Lines with Botulinum Toxin Type A: GLO 3 + 2: A Precise Technique Based on Anatomy.
Good patient outcomes after treatment of the glabellar complex with botulinum toxin type A entail elimination of glabellar lines and maintenance of a natural eyebrow position. A precise injection technique that accurately targets the muscle…
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Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement?
[BACKGROUND] Botulinum toxin type A (BoNTA) is standard of care for glabellar lines ameliorization. DaxibotulinumtoxinA for Injection (DAXI) is a new BoNTA with a unique formulation representing the latest advancement in BoNTA technology. T…
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Dysphagia and Muscle Weakness Secondary to Botulinum Toxin Type A Treatment of Cervical Dystonia: A Drug Class Analysis of Prescribing Information.
The first-line management of cervical dystonia (CD) symptoms is intramuscular injection of botulinum toxin type A (BoNTA). However, a comparison of safety among BoNTAs is difficult because, per regulatory authorities, units of BoNTA activit…
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Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials.
DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two p…
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A technology evaluation of the atypical use of a CPP-containing peptide in the formulation and performance of a clinical botulinum toxin product.
[INTRODUCTION] Cell-penetrating peptides (CPPs), are small peptides that facilitate cytosolic access and, thus, transport of therapeutic macromolecules to intracellular sites when conjugated to cargo proteins. As with all new delivery platf…
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Bridging the Gap: Sustained Treatment Effect of Glabellar Lines With Twice-A-Year Treatment With DaxibotulinumtoxinA.
[BACKGROUND] To achieve natural-looking outcomes when treating dynamic lines with botulinum toxin (BoNT), retreatment must be timed such that the patient maintains a relatively constant aesthetic outcome. Although first-generation BoNT prod…
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Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines.
DaxibotulinumtoxinA-lanm for injection (DAXI), a novel botulinum toxin type A formulation, contains a purified 150-kD core neurotoxin (daxibotulinumtoxinA) and proprietary stabilizing peptide (RTP004), and is approved for glabellar line tre…
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Impact of DaxibotulinumtoxinA for Injection on Brow Position and Frontalis Muscle Activity Following Treatment of Glabellar Lines.
[BACKGROUND] Botulinum toxin type A (BoNTA) injections for the treatment of facial lines may lead to pleasant or undesirable changes in eyebrow height and position. [OBJECTIVES] The aim of this study was to evaluate the impact of glabellar…
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Integrative Assessment for Optimizing Aesthetic Outcomes When Treating Glabellar Lines With Botulinum Toxin Type A: An Appreciation of the Role of the Frontalis.
Despite the perception that treatment of glabellar lines with botulinum toxin A is straightforward, the reality is that the glabellar region contains a number of interrelated muscles. To avoid adverse outcomes, practitioners need to appreci…
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Impact of Glabellar Injection Technique With DaxibotulinumtoxinA for Injection on Brow Position.
[BACKGROUND] Precise injection technique is vital for avoiding suboptimal eyebrow position when treating glabellar lines with botulinum toxin type A. [OBJECTIVES] The aim of this study was to evaluate the impact of glabellar injection tech…
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Biochemical Stability and Microbial Control of Reconstituted DaxibotulinumtoxinA-lanm for Injection.
DaxibotulinumtoxinA-lanm for injection (DAXI) is a unique US Food and Drug Administration-approved product comprising daxibotulinumtoxinA and a stabilizing excipient peptide (RTP004). DAXI has a longer-labeled shelf life (72 h) following re…
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DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study.
[BACKGROUND] DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glab…
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Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program.
[BACKGROUND] Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not w…
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Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection.
[BACKGROUND] DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin in development that has demonstrated efficacy on dynamic glabellar lines. [OBJECTIVE] To evaluate the effect of repeated DAXI treatment on static glabellar li…
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Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A.
Botulinum toxin type A (BoNTA) products are widely used for therapeutic and aesthetic indications, but there is a need for longer-lasting treatments that maintain symptom relief between injections and reduce the frequency of re-treatment. D…
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Maximizing Panfacial Aesthetic Outcomes: Findings and Recommendations From the HARMONY Study.
[BACKGROUND] Aesthetic medicine has evolved from targeting individual treatment areas to a global approach of panfacial rejuvenation. HARMONY was the first clinical study to systematically demonstrate positive physical and psychosocial impa…
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DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2).
[BACKGROUND] DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 week…
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Lip and Perioral Enhancement With Hyaluronic Acid Dermal Fillers in Individuals With Skin of Color.
[BACKGROUND] Individuals with skin of color are underrepresented in studies of lip and perioral enhancement. [OBJECTIVE] To examine the effectiveness and safety of hyaluronic acid (HA) dermal filler treatment for lip and perioral enhanceme…
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Preventive, Cumulative Effects of Botulinum Toxin Type A in Facial Aesthetics.
[BACKGROUND] Botulinum toxin Type A (BoNTA) is the gold standard for the treatment of dynamic rhytides in the face. Recently, clinical observation suggests that individuals who receive regular injections of BoNTA experience ongoing wrinkle …
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A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: Injection Techniques and Treatment Characteristics From the HARMONY Study.
[BACKGROUND] The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures. [OBJECTIVE] Provide details of…