A phase III, multi-center, randomized, double blind, active and placebo control, single dose trial to demonstrate the efficacy and safety of DWP-450 in adult subjects for treatment of moderate-to-severe glabellar lines

Trial Profile

A phase III, multi-center, randomized, double blind, active and placebo control, single dose trial to demonstrate the efficacy and safety of DWP-450 in adult subjects for treatment of moderate-to-severe glabellar lines

Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2017

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Glabellar lines
  • Focus Registrational; Therapeutic Use
  • Acronyms EV003
  • Sponsors Evolus
  • Most Recent Events

    • 26 Oct 2017 According to an Evolus media release, Health Canada has accepted for review the New Drug Submission (NDS) for prabotulinumtoxinA, a 900 kilodalton (kDa) Botulinum toxin Type A, for the treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows. Application is supported by results of this trial.
    • 20 Jul 2017 According to an Evolus media release, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for DWP-450 for the treatment of adult patients with glabellar lines for review under the Centralized Procedure .The MAA application is supported by the results of this trial.
    • 06 Apr 2017 The trial has been completed in United Kingdom (end date: 27-04-2016), according to the European Clinical Trials Database.
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