A comparative, prospective, split-face, blind study of the efficacy of two botulinum toxin type A drugs (Disport® and Xeomin®) used to correct lateral periorbital wrinkles

Abstract

A prospective- blind- split-face- comparative study with evaluation of clinical efficacy- tolerability- and safety parameters of two botulinum toxin A (BTA) products (the one containing complexing proteins — Disport®- Ipsen- France/ abobotulinumtoxinA and the one free from complexing proteins — Xeomin®- Merz Pharma- Germany/incobotulinumtoxinA) used for correction of lateral periorbital wrinkles (crow's feet) was performed (at that- electromyographic evaluation of changes in functions of the orbicular muscle of eye was performed for the first time). Materials and Methods. Single injections of both BTA products with equal dose ratio of 3:1 (27 IU Disport® and 9 IU Xeomin®) were performed simultaneously to the right and left side half of the face (orbicular muscles of eye)- respectively- to each of 20 volunteers (women at the age of 40.9) with marked and moderate lateral periorbital wrinkles (2—3 degree according to 4-point Facial Wrinkle Scale/FWS). Clinical and electromyographic assessment was performed 2 weeks- 4 and 6 months after injections. Results. The effect of single dosing of Disport® and Xeomin® did not significantly differ at all assessment time points: both for primary efficacy criterion and for all secondary efficacy criteria; as well as for clinical evaluation by the investigator-subjects’ self-evaluation- and dynamics of M-response parameters for the orbicular muscle of eye. Good tolerability and safety were registered. Conclusion. Study results provided convincing evidence that Disport® and Xeomin® used in accordance with the proposed protocol had a comparable effect and duration of the effect on lateral periotbital wrinkles and the orbicular muscle of eye.