Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines.
Dermatol Surg
; 39(4): 551-8, 2013 Apr.
Article
em En
| MEDLINE
| ID: mdl-23379292
ABSTRACT
BACKGROUND:
Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins.OBJECTIVE:
To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS ANDMETHODS:
Two hundred seventy-six patients were randomized 21 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration-mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120.RESULTS:
Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated.CONCLUSION:
A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Envelhecimento da Pele
/
Toxinas Botulínicas Tipo A
/
Fármacos Neuromusculares
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Dermatol Surg
Assunto da revista:
DERMATOLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Canadá