Efficacy and safety of neuronox^® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind, active-controlled study

Abstract

Introduction

Neuronox^® has not yet been investigated for its efficacy and safety in the treatment of lateral canthal lines (LCL).

Methods

This study was a randomized, double-blind, active drug controlled, multicenter, 16 week, Phase I/III study designed to determine the non-inferiority of Neuronox^® compared to onabotulinumtoxin A (ONA) in the treatment of moderate to severe LCL. Thirty subjects in Phase I and 220 subjects in Phase III were randomized in a 1:1 ratio to receive a single treatment (24 U) of either Neuronox^® or ONA. The primary endpoint of the Phase III study was the responder rate according to the proportion of subjects achieving Grade 0 (none) or 1 (mild) from 2 (moderate) or 3 (severe) in LCL severity at maximum smile as assessed by the investigators at Week 4. Additional efficacy endpoints and safety endpoints (adverse events) were also evaluated.

Results

The primary endpoint was achieved as the proportion of responders was 83% for both Neuronox^® and ONA, thus, supporting the non-inferiority of Neuronox^® compare to ONA. The two groups also showed no statistical differences in safety analyses.

Conclusion

Treatment of moderate to severe LCL with Neuronox^® was effective and well-tolerated.

Keywords:

• Botulinum toxin type A
• neuronox
• lateral canthal lines
• onabotulinumtoxin a
• efficacy
• safety

Acknowledgments

We would like to thank Jongeun Lee and Donghwi Jang for their assistance organizing data in the compilation of this manuscript. We also want to thank all employees at Medytox Inc. for their contribution to this study.

Disclosure statement

W.S. Lee is an employee of Medytox Inc. The other authors have no conflict of interest.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Medytox provided the research funds and drugs used in this study (Neuronox^®; Botulinum Toxin Type A; Medytox Inc., Korea).