A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients

Rzany, Berthold-Josef; Ascher, Benjamin; Avelar, Rui L.; Bergdahl, Jesper; Bertucci, Vince; Bodokh, Isaac; Carruthers, James Alastair; Cartier, Hugues; Delmar, Henry; Denfeld, Ralf; Gross, John E.; Heckmann, Marc; Hedén, Per; Hilton, Said; Inglefield, Christopher; Ogilvie, Patricia; Sattler, Gerhard; Sebastian, Michael; Solish, Nowell; Swift, Arthur; Trévidic, Patrick

doi:10.1093/asj/sjz110

Cited by 18 publications

(48 citation statements)

References 4 publications

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“…In a 150‐day, multicenter, double‐blind, single‐dose (corresponding to FDA‐approved doses) noninferiority trial comparing PrabotulinumtoxinA to OnabotulinumtoxinA at the same 20U dose (approved dose for GL) and placebo, a 5:5:1 ratio of 540 patients were administered 0.1mL of the corresponding treatment to each of the 5 glabellar injection points. Although not quite reaching statistical significance, there was indication of increased duration of effect for PrabotulinumtoxinA 71 …”

Section: Postulate IVmentioning

confidence: 84%

“…78 PrabotulinumtoxinA and OnabotulinumtoxinA may have a 1:1 or higher ratio. 71,72 AbobotulinumtoxinA and OnabotulinumtoxinA seem to have a 2:1 or 2.5:1 equivalence ratio, although the variance of ratios used among studies ranges from 1.5:1 to 3:1. [73][74][75][76][77]79 The direct measurements of the quantity of the mean active and interpreting strong clinical trials.…”

Section: Molecular Potencymentioning

confidence: 99%

“…Generally, IncobotulinumtoxinA and OnabotulinumtoxinA may have close to a 1:1 dose equivalence ratio, but some dispute this 78 . PrabotulinumtoxinA and OnabotulinumtoxinA may have a 1:1 or higher ratio 71,72 . AbobotulinumtoxinA and OnabotulinumtoxinA seem to have a 2:1 or 2.5:1 equivalence ratio, although the variance of ratios used among studies ranges from 1.5:1 to 3:1 73‐77,79 .…”

Section: Postulate IImentioning

confidence: 99%

“…65,66 Those that do attempt to compare brands have somewhat inconsistent and conflicting results, which may be due to a plethora of confounding variables that are difficult to control in addition to the lack of consensus regarding dose unit conversion ratios upon which they are based. 18,[65][66][67][68][69][70][71][72][73][74][75][76][77] Generally, IncobotulinumtoxinA and OnabotulinumtoxinA may have close to a 1:1 dose equivalence ratio, but some dispute this. 78 PrabotulinumtoxinA and OnabotulinumtoxinA may have a 1:1 or higher ratio.…”

Section: Molecular Potencymentioning

confidence: 99%

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The mechanisms of action and use of botulinum neurotoxin type A in aesthetics: Key Clinical Postulates II

Nestor

Arnold

Fischer

2020

J of Cosmetic Dermatology

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Background The literature on botulinum neurotoxin type A (BoNT‐A) is extensive, often contradictory, and confounded by a competitive market of products and research attempting to distinguish brand individuality. Methods A comprehensive review of literature on the principles of BoNT‐A in aesthetics as well as clinical examples. Results In 2017, the Eight Key Clinical Postulates were formulated as a guide for the aesthetic practitioner in understanding BoNT‐A pharmacodynamics and to compare different toxins. These are now updated to include (a) All type A toxins act identically; (b) The mathematical relationship between toxin and receptor is the basis of efficacy, and clinical efficacy is influenced by molecular potency and patient attributes including muscle mass, gender, age, and ethnicity; (c) Efficacy, onset, and duration are functions of “molecular potency” defined as the number of active 150 kDa molecules available for binding; (d) “Molecular potency” is difficult to objectively quantify for commercially available toxins; (e) Up to a point, increased molecular potency decreases time to onset and increases duration of effect, and the “Molecular Potency Quotient” is a construct for comparing molecular potency commercial cost; (f) The area of effect of a toxin injection is dependent upon molecular potency, diffusion (passive), and spread (active); (g) Differing reconstitution volumes; and (h) Increased number of injection sites can affect spread, onset, and duration of effect. Conclusions The principles of BoNT‐A use in aesthetics are complex yet understandable as outlined in the framework of the updated Eight Key Clinical Postulates and serves as a useful tool for providing the most effective treatment and interpreting research on present and future toxin formulations.

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Section: Postulate IVmentioning

confidence: 84%

Section: Molecular Potencymentioning

confidence: 99%

Section: Postulate IImentioning

confidence: 99%

Section: Molecular Potencymentioning

confidence: 99%

See 2 more Smart Citations

The mechanisms of action and use of botulinum neurotoxin type A in aesthetics: Key Clinical Postulates II

Nestor

Arnold

Fischer

2020

J of Cosmetic Dermatology

View full text Add to dashboard Cite

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“…± EV-001 and EV-002 phase III trials reported in 1 full-text article (Beer et al 6 ). EV-005 phase III trial reported in 1 full-text article (Rzany et al 12 ).…”

Section: Methodsmentioning

confidence: 99%

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

et al. 2020

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Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

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