NCT02428608

Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006

A Multi-center, Open Label, Single Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: Evolus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.

Detailed description

Up to five hundred and thirty (530) subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study. Subjects with moderate-to-severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	DWP-450 (Botulinum purified neurotoxin, Type A)	Botulinum toxin, Type A

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2015-04-29
• Last updated: 2019-04-24
• Results posted: 2019-02-05

Locations

1 site across 1 country: United States