Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies.
Dermatol Surg
; 45(11): 1381-1393, 2019 11.
Article
em En
| MEDLINE
| ID: mdl-30893162
ABSTRACT
BACKGROUND:
PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.OBJECTIVE:
To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines. MATERIALS ANDMETHODS:
Adult subjects (n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 31 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study.RESULTS:
Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related.CONCLUSION:
In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Envelhecimento da Pele
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Técnicas Cosméticas
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Toxinas Botulínicas Tipo A
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Fármacos Neuromusculares
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article