A Phase III, Multi-center, Randomized, Double Blind, Placebo-controlled, Single Dose, Trial to Demonstrate the Safety and Efficacy of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

Trial Profile

A Phase III, Multi-center, Randomized, Double Blind, Placebo-controlled, Single Dose, Trial to Demonstrate the Safety and Efficacy of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2017

At a glance

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

    • 19 Jul 2017 According to an Evolus media release, Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for review of DWP-450, a Botulinum toxin Type A for the treatment of adult patients with glabellar lines (frown lines) between the eyebrows. This BLA is based on the results of EV-001,EV-002, EV-004 and EV-006 clinical trials.
    • 16 May 2017 According to an ALPHAEON Corporation media release, based on the data from EV-001,EV-002, EV-004 and EV-006 trials Evolus Inc. has submitted a Biologics License Application (BLA) for DWP-450, a Botulinum toxin Type A, to the U.S. Food and Drug Administration (FDA) seeking approval for the treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows.
    • 18 Dec 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top