Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies.

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 improvem

SUBMITTER: Beer KR 

PROVIDER: S-EPMC6819028 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature