Respective Potencies of Botox® and Dysport® in a Human Skin Model : A Randomized, Double-blind Study
Identifieur interne : 002E15 ( Main/Merge ); précédent : 002E14; suivant : 002E16Respective Potencies of Botox® and Dysport® in a Human Skin Model : A Randomized, Double-blind Study
Auteurs : Gottfried Kranz [Autriche] ; Dietrich Haubenberger [Autriche] ; Bemhard Voller [Autriche] ; Martin Posch [Autriche] ; Peter Schnider [Autriche] ; Eduard Auff [Autriche] ; Thomas Sycha [Autriche]Source :
- Movement disorders [ 0885-3185 ] ; 2009.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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.
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<series><title level="j" type="main">Movement disorders</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bontoxilysin</term>
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<term>Sweat</term>
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<front><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.</div>
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