NCT02184988

Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Evolus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.

Detailed description

Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study. Subjects with moderate or 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. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment. 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	Botulinum purified neurotoxin, Type A	The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-07-09
• Last updated: 2019-04-24
• Results posted: 2019-02-05

Locations

1 site across 1 country: United States