History of Botulinum Toxin for Medical and Aesthetic Use

Carruthers, Alastair; Carruthers, Jean

doi:10.1002/9781118661833.ch1

Cited by 10 publications

(10 citation statements)

References 88 publications

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“…Clostridium botulinum toxin type A (BoNT-A) is a potent neurotoxin with 7 serotypes (A-G). 5 All serotypes of BoNT-A act selectively on peripheral cholinergic nerve endings, blocking/inhibiting release of acetylcholine, and reducing muscle contraction. 5 BoNT-A smooths facial lines, including GL, due to its efficacy in temporarily relaxing the procerus and corrugator muscle complex.…”

mentioning

confidence: 99%

“…5 All serotypes of BoNT-A act selectively on peripheral cholinergic nerve endings, blocking/inhibiting release of acetylcholine, and reducing muscle contraction. 5 BoNT-A smooths facial lines, including GL, due to its efficacy in temporarily relaxing the procerus and corrugator muscle complex. 5 The efficacy and safety of the 3 most commonly used BoNT-As (abobotulinumtoxinA: Dysport, Ipsen Ltd, Slough, UK/Azzalure, Galderma SA, Lausanne, Switzerland; incobotulinumtoxinA: Bocouture/Xeomin, Merz Pharmaceuticals, Inc., Frankfurt, Germany; onabotulinumtoxinA: Vistabel/Botox, Allergan, Inc., Irvine, CA) in improving the appearance of moderate-to-severe GL have been evaluated in several double-blind, randomized, placebo-controlled, phase 3 clinical trials over the last 15 years.…”

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confidence: 99%

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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

Ascher¹,

Rzany²,

Kestemont

et al. 2019

Aesthetic Surgery Journal

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BackgroundSafety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection.ObjectivesThe 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.MethodsThe 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.ResultsResponder 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.ConclusionsASI 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.Level of Evidence: 1

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mentioning

confidence: 99%

mentioning

confidence: 99%

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

Ascher¹,

Rzany²,

Kestemont

et al. 2019

Aesthetic Surgery Journal

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“…[10][11][12] Historically, composite outcome measures used in rehabilitation studies have tended to be generated from passive resistance measures, for example, by summing modified Ashworth Scale scores of multiple joints to assess muscle tone changes in the affected limb. [18][19][20][21][22][23][24][25][26][27][28][29][30] Although helpful, these approaches have overlooked assessment of active motion or active function. A "composite functional index" has been developed, which assesses perceived function involving mostly passive movements.…”

Section: Correlations Between CX a And Functional Outcomesmentioning

confidence: 99%

Composite active range of motion (CX_A) and relationship with active function in upper and lower limb spastic paresis

Bayle

Maisonobe

Raymond³

et al. 2020

Clin Rehabil

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Objective: The aim of this study is to evaluate a novel composite measure of active range of motion (XA) and determine whether this measure correlates with active function. Design: Post hoc analysis of two randomized, placebo-controlled, double-blind studies with open-label extensions exploring changes in active function with abobotulinumtoxinA. Setting: Tertiary rehabilitation centers in Australia, Europe, and the United States. Subjects: Adults with upper ( n = 254) or lower ( n = 345) limb spastic paresis following stroke or brain trauma. Interventions: AbobotulinumtoxinA (⩽5 treatment cycles) in the upper or lower limb. Main measures: XA was used to calculate a novel composite measure (CXA), defined as the sum of XA against elbow, wrist, and extrinsic finger flexors (upper limb) or soleus and gastrocnemius muscles (lower limb). Active function was assessed by the Modified Frenchay Scale and 10-m comfortable barefoot walking speed in the upper limb and lower limb, respectively. Correlations between CXA and active function at Weeks 4 and 12 of open-label cycles were explored. Results: CXA and active function were moderately correlated in the upper limb ( P < 0.0001–0.0004, r = 0.476–0.636) and weakly correlated in the lower limb ( P < 0.0001–0.0284, r = 0.186–0.285) at Weeks 4 and 12 of each open-label cycle. Changes in CXA and active function were weakly correlated only in the upper limb (Cycle 2 Week 12, P = 0.0160, r = 0.213; Cycle 3 Week 4, P = 0.0031, r = 0.296). Across cycles, CXA improvements peaked at Week 4, while functional improvements peaked at Week 12. Conclusion: CXA is a valid measure for functional impairments in spastic paresis. CXA improvements following abobotulinumtoxinA injection correlated with and preceded active functional improvements.

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“…A cholinergic neuron is a nerve cell that mainly uses the neurotransmitter ACh to send its messages to target organs. The development of a BoNT-A treatment, the first microbial toxin treatment used in humans, began with the pathophysiological hypothesis that toxins extracted from spoiled sausage interfere with signaling in the motor nervous system in a book published by Justinus Wurst Kerner in 1822 [6]. Then, Burgen et al [7] found that BoNT interferes with muscle nerve transmission in 1949.…”

Section: Botulinum Neurotoxin: a Miracle Poisonmentioning

confidence: 99%

Scientific review of the aesthetic uses of botulinum toxin type A

Park

Ahn²

2021

Arch Craniofac Surg

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Botulinum toxin type A (BoNT-A), onabotulinumtoxinA (Botox) was approved by the United States Food and Drug Administration for temporary improvement of glabellar lines in patients 65 years and younger in 2002, and has also been used widely for aesthetic purposes such as hyperhidrosis, body shape contouring, and other noninvasive facial procedures. BoNT-A inhibits presynaptic exocytosis of acetylcholine (ACh)-containing vesicles into the neuromuscular junction at cholinergic nerve endings of the peripheral nervous system, thereby paralyzing skeletal muscles. ACh is the most broadly used neurotransmitter in the somatic nervous system, preganglionic and postganglionic fibers of parasympathetic nerves, and preganglionic fibers or postganglionic sudomotor nerves of sympathetic nerves. The scientific basis for using BoNT-A in various cosmetic procedures is that its function goes beyond the dual role of muscle paralysis and neuromodulation by inhibiting the secretion of ACh. Although the major target organs for aesthetic procedures are facial expression muscles, skeletal body muscles, salivary glands, and sweat glands, which are innervated by the somatic or autonomic nerves of the peripheral cholinergic nerve system, few studies have attempted to directly explain the anatomy of the areas targeted for injection by addressing the neural physiology and rationale for specific aesthetic applications of BoNT-A therapy. In this article, we classify the various cosmetic uses of BoNT-A according to the relevant component of the peripheral nervous system, and describe scientific theories regarding the anatomy and physiology of the cholinergic nervous system. We also review critical physiological factors and conditions influencing the efficacy of BoNT-A for the rational aesthetic use of BoNT-A. We hope that this comprehensive review helps promote management policies to support long-term, safe, successful practice. Furthermore, based on this, we look forward to developing and expanding new advanced indications for the aesthetic use of BoNT-A in the future.

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History of Botulinum Toxin for Medical and Aesthetic Use

Cited by 10 publications

References 88 publications

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

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

Composite active range of motion (CX_A) and relationship with active function in upper and lower limb spastic paresis

Scientific review of the aesthetic uses of botulinum toxin type A

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History of Botulinum Toxin for Medical and Aesthetic Use

Cited by 10 publications

References 88 publications

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

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

Composite active range of motion (CXA) and relationship with active function in upper and lower limb spastic paresis

Scientific review of the aesthetic uses of botulinum toxin type A

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Product

Resources

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Composite active range of motion (CX_A) and relationship with active function in upper and lower limb spastic paresis