Comparison of Four Botulinum Neurotoxin Type A Preparations in the Treatment of Hyperdynamic Forehead Lines in Men: A Pilot Study

February 2012 | Volume 11 | Issue 2 | Original Article | 216 | Copyright © February 2012

Abstract

Background:Botulinum neurotoxin type A (BTXA) offers a minimally invasive approach for the treatment of facial rhytides and has been well accepted by male patients. However, few comparative studies about the efficacy of the different BTXA preparations in this emerging group of patients are available.
Objective: To access the efficacy of four BTXA preparations in the treatment of hyperdynamic forehead lines in men.
Methods: Twelve male patients with a mean age of 30.5±5.26 years, with moderate or severe hyperdynamic forehead lines on a facial wrinkle scale (FWS), were involved in the study. Using an intra-individual controlled study design, either 17 mouse units (m.U) of Botox, Prosigne, and Xeomin or 51 Speywood units (s.U) of Dysport were applied to each side of a patient´s forehead. Subjects with absent or mild forehead lines were considered responders. Study evaluations were performed monthly up to day 150.
Results: All patients responded in a side-to-side evaluation and no asymmetries or differences in the degree of reduction of hyperdynamic forehead lines were noted at day 30 and day 60 ( P =0.340). Analysis of all combined forehead sides treated with a given BTXA did not show statistically significant differences in terms of maintenance of improvement between different BTXA preparations at day 150 ( P =0.528).
Conclusion: The data obtained in this study revealed a similar effectiveness of the BTXA preparations evaluated in the treatment of hyperdynamic forehead lines in men, when considering a dose-ratio of 1 m.U of Botox, Xeomin or Prosigne to 3 s.U of Dysport.

J Drugs Dermatol. 2012;11(2):216-219.

INTRODUCTION

The use of botulinum neurotoxin type A offers a minimally invasive approach for the treatment of facial rhytides. It is often the first cosmetic procedure to be chosen by male patients in dermatological practice.1
In Brazil,four preparations of botulinum neurotoxin type A have been approved by the national sanitary surveillance agency and are available for aesthesic use: onabotulinumtoxin A (Botox, Allergan, Irvine, CA, USA); abobotulinumtoxin A (Dysport, Ipsen Pharma, Boulogne-Billancourt, France); incobotulinumtoxin A (Xeomin, Merz Pharmaceuticals GmbH, Frankfurt, Germany); and a recently released Chinese botulinum toxin preparation (Prosigne, Lanzhou Biological Products Institute, Lanzhou, China). These formulations differ with regards to the fermentation technique used in the manufacturing process as well as in terms of their additives and the presence of stabilizing proteins. Among the commercially available toxins, Xeomin is the only one that contains the pure 150 kDa neurotoxin. The others are represented by protein complexes of 500 to 900 kD that depend on molecule dissociation to release the same 150 kDa active toxin that will target the tissue.2 The presence of such protein additives are thought to influence the in vivo immunogenic toxin properties.3-5
Since few comparative studies on the efficacy of these products are found in the literature, we developed a randomized, double- blind, split-face pilot study to evaluate the efficacy of four botulinum neurotoxins when used for the treatment of male patients with hyperdynamic forehead lines.

METHODS

Twelve healthy male patients with a mean age of 30.5±5.26 years and having hyperdynamic forehead lines classified at