NCT02334436

A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Evolus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects

Detailed description

Three hundred and twenty-four eligible subjects will be randomly assigned 3:1 to receive DWP-450 or placebo. Safety and efficacy will be assessed on Days 2, 7, 14, 30, 90, 120 and 150. The primary efficacy end point assesses the effectiveness of the DWP-450 against placebo on Day 30 in a superiority design.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin, Type A	Botulinum toxin, Type A
OTHER	0.9% sterile, unpreserved saline	Placebo Comparator Arm

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2015-01-08
• Last updated: 2019-03-27
• Results posted: 2019-02-27

Locations

1 site across 1 country: United States