Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies

Beer, Kenneth; Shamban, Ava Theresa; Avelar, Rui L.; Gross, John E.; Jonker, Anneke

doi:10.1097/dss.0000000000001903

Cited by 40 publications

(73 citation statements)

References 2 publications

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“…AbobotulinumtoxinA (Dysport/Azzalure) has a complex size of ~500 kDa but has not been precisely disclosed by the manufacturer 15,16 . The newest FDA‐approved BoNT‐A formulation, PrabotulinumtoxinA (Jeuveau) also has 900 kDa complexes 14,18 . DaxibotulinumtoxinA (DAXI) consists of 150 kDa toxin formulated with a stabilizing excipient peptide 3 .…”

Section: Postulate Imentioning

confidence: 99%

“…Few well‐designed, controlled, randomized studies directly compare formulations of BoNT‐A 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 18,65‐77 . Generally, IncobotulinumtoxinA and OnabotulinumtoxinA may have close to a 1:1 dose equivalence ratio, but some dispute this 78 .…”

Section: Postulate IImentioning

confidence: 99%

“…15,16 The newest FDA-approved BoNT-A formulation, PrabotulinumtoxinA (Jeuveau) also has 900 kDa complexes. 14,18 DaxibotulinumtoxinA (DAXI) consists of 150 kDa toxin formulated with a stabilizing excipient peptide. 3 The diluents used in each com- mouse toxicity assays as there is no standardized assay as of yet.…”

Section: While Differences Exist In Manufacturing and Formulation Allmentioning

confidence: 99%

“…The mechanism by which these APs were suggested to enhance BoNT-A activity was by enhancing its zinc-dependent endopeptidase activity via reduction of the disulfide bond TA B L E 1 Comparison of FDA-approved and soon to be approved botulinum toxins. 3,11,18,60,147 that links the heavy and lights chains. 23,24 This was exemplified in a 2004 study by Sharma and Singh who isolated one of the NAP components, specifically hemagglutinin-33 (Hn-33).…”

Section: While Differences Exist In Manufacturing and Formulation Allmentioning

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 Imentioning

confidence: 99%

Section: Postulate IImentioning

confidence: 99%

Section: While Differences Exist In Manufacturing and Formulation Allmentioning

confidence: 99%

Section: While Differences Exist In Manufacturing and Formulation Allmentioning

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

show abstract

“…Limitations of this study include its population of mainly white women, so the generalizability of the findings may be affected, although this is also the case in other trials with BoNTA for glabellar lines. 12 , 13 , 15 – 19 However, unlike most clinical trials of a BoNTA for facial wrinkles, subjects who had previously received a BoNTA were eligible to participate in SAKURA 3 and comprised 40% of the population. This is reflective of the type of patients seen in clinical practice.…”

Section: Discussionmentioning

confidence: 99%