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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 and methods
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 3:1 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.
SUBMITTER: Beer KR
PROVIDER: S-EPMC6819028 | biostudies-literature | 2019 Nov
REPOSITORIES: biostudies-literature
Beer Kenneth R KR Shamban Ava Theresa AT Avelar Rui L RL Gross John E JE Jonker Anneke A
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] 20191101 11
<h4>Background</h4>PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.<h4>Objective</h4>To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines.<h4>Materials and methods</h4>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-d ...[more]