A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.
Phase of Trial: Phase II
Latest Information Update: 19 Jul 2017
At a glance
- Drugs Botulinum toxin A (Primary)
- Indications Glabellar lines
- Focus Adverse reactions
- Acronyms EV-004
- Sponsors Evolus
- 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 record.