Efficacy and safety of neuronox® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind, active-controlled study.
J Dermatolog Treat
; 32(5): 561-567, 2021 Aug.
Article
em En
| MEDLINE
| ID: mdl-31665942
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 11 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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Envelhecimento da Pele
/
Toxinas Botulínicas Tipo A
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article