Movement Disorders (revue)

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Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study

Identifieur interne : 002073 ( Main/Exploration ); précédent : 002072; suivant : 002074

Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study

Auteurs : Gottfried Kranz [Autriche] ; Dietrich Haubenberger [Autriche] ; Bernhard Voller [Autriche] ; Martin Posch [Autriche] ; Peter Schnider [Autriche] ; Eduard Auff [Autriche] ; Thomas Sycha [Autriche]

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RBID : ISTEX:659C85D9163DDE3946E345437095DB5099F7C9D5

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English descriptors

Abstract

Mouse units used to quantify the activity of botulinum A toxin preparations are not equivalent and issues concerning efficacy and safety remain with regard to their respective potencies and diffusion qualities in human tissue. We compared the effects of Botox® (BOT) and Dysport® (DYS) in different doses and dilutions in a human skin model. Eighteen (8 women, 10 men) healthy volunteers, aged 28.4 years ± 5.7 years were injected intradermally with pure saline, BOT and DYS at 16 points in the abdomen in random order and in a double‐blind condition, using two conversion ratios (1:3 and 1:4) and three different dilution schemes. For an objective outcome, the Ninhydrin sweat test was used to compare the anhidrotic areas. Both preparations showed a linear dose and dilution relationship with similar variances of responses for anhidrosis and hypohidrosis, indicating the same reliability of response. The dose equivalence conversion ratios (BOT: DYS) were 1:1.3 for anhidrosis and 1:1.6 for hypohidrosis (1:1.1‐1.5 and 1:1.4‐1.8 95% confidence intervals). The diffusion characteristics of both products were similar. A dose equivalence factor of more than 1:2 (BOT:DYS) is not supported by these objective and reproducible data. © 2008 Movement Disorder Society

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DOI: 10.1002/mds.22336


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<term>Botulinum Toxins, Type A (pharmacokinetics)</term>
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<term>Nervous system diseases</term>
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<div type="abstract" xml:lang="en">Mouse units used to quantify the activity of botulinum A toxin preparations are not equivalent and issues concerning efficacy and safety remain with regard to their respective potencies and diffusion qualities in human tissue. We compared the effects of Botox® (BOT) and Dysport® (DYS) in different doses and dilutions in a human skin model. Eighteen (8 women, 10 men) healthy volunteers, aged 28.4 years ± 5.7 years were injected intradermally with pure saline, BOT and DYS at 16 points in the abdomen in random order and in a double‐blind condition, using two conversion ratios (1:3 and 1:4) and three different dilution schemes. For an objective outcome, the Ninhydrin sweat test was used to compare the anhidrotic areas. Both preparations showed a linear dose and dilution relationship with similar variances of responses for anhidrosis and hypohidrosis, indicating the same reliability of response. The dose equivalence conversion ratios (BOT: DYS) were 1:1.3 for anhidrosis and 1:1.6 for hypohidrosis (1:1.1‐1.5 and 1:1.4‐1.8 95% confidence intervals). The diffusion characteristics of both products were similar. A dose equivalence factor of more than 1:2 (BOT:DYS) is not supported by these objective and reproducible data. © 2008 Movement Disorder Society</div>
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