OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects.
Aesthetic Plast Surg
; 41(5): 1186-1197, 2017 Oct.
Article
em En
| MEDLINE
| ID: mdl-28733805
ABSTRACT
BACKGROUND:
This study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow's feet lines (CFL).METHODS:
This phase 3, multicenter, double-blind, randomized study included 2 treatment periods 6-month placebo-controlled period followed by a 7-month open-label period. In period 1, subjects with moderate to severe CFL received onabotulinumtoxinA 24 U (n = 104) or 12 U (n = 99), or placebo (n = 97). In period 2, placebo subjects switched to onabotulinumtoxinA 24 U or 12 U (double-blind dose). Up to 5 total treatments were permitted for subjects meeting re-treatment criteria. The primary efficacy measure was the proportion of investigator-assessed responders (achieving CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide [FWS-A] at day 30 of treatment 1). Additional endpoints included other responders (achieving at least 1-grade improvement at maximum smile and at rest using the FWS-A at day 30), responders at other time points, duration of effect, subject-reported outcomes, and safety.RESULTS:
All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA 24 and 12 U groups (68.3 and 56.6%, respectively) compared with the placebo group (8.2%). Efficacy results were consistent over repeated treatments, and subjects' self-assessed outcomes were similar to investigator-assessed results.CONCLUSIONS:
Treatment with onabotulinumtoxinA 24 and 12 U improved the appearance of CFL in Japanese subjects and was well tolerated, with no new safety findings. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Rejuvenescimento
/
Envelhecimento da Pele
/
Toxinas Botulínicas Tipo A
/
Fármacos Neuromusculares
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Aesthetic Plast Surg
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Japão