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

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.

Effect of Botulinum Toxin Concentration on Reduction in Sweating: A Randomized, Double-blind Study

“…This study, as well as others, shows that the level of dilution of the products is important for optimal effect (12,13,18,19). However, although Botox and Dysport are approved for treatment of axillary hyperhidrosis, most dose-response studies are still performed on muscles and α-motor neurones, which differ from autonomic sudomotor neurones.…”

“…The method used in this study is very simple and easy to perform with reproducible results (12). Kranz et al have compared the sweat reducing effect of Botox and Dysport with corresponding results (13). They have used a similar method but chose abdominal skin, which provides homogenous sweating conditions.…”

“…The sample size estimation in this exploratory study was not based on statistical criteria, but on similar studies (12,13).…”

Botox and Dysport: Is there a dose conversion ratio in dermatology and aesthetic medicine?

“…Studies on anhidrotic action halos have shown equivalent halo size at a dose ratio between 2.5:1 12,13 and 2:1, 14 and larger halos after Dysport with a ratio of 3:1. 1 Although these latter studies have been variously interpreted, in particular with the claim that Dysport diffuses more than Botox, our own work suggests that this is a simple dose effect.…”

Seitenvergleich zweier Botulinumtoxin-A-Präparate bei lateroorbitalen Mimikfalten

“…Während die Dosis von Botox® und Dysport® anhand der angegebenen Einheiten (Mouse-Units: U) nicht umrechenbar ist und das Wirkungsverhältnis im Rahmen multipler Studien im Bereich von 1:2,5 bis 1:6 angegeben wird [4,6,9,13,16], postulierte der Hersteller für Xeomin® eine Wirkstärke zu Botox® im Verhältnis 1:1.…”