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

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: Botulinum purified neurotoxin, Type A

• Registration Number: NCT02184988
• Lead Sponsor: Evolus, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Study Start: 2014-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Disposition First Submitted: 2017-02-01
• Disposition First Submitted QC: 2017-03-20
• Disposition First Posted: 2017-03-21
• Results First Submitted: 2019-01-11
• Results First Submitted QC: 2019-01-11
• Results First Posted: 2019-02-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum neurotoxin, Type A	Botulinum purified neurotoxin, Type A	DWP-450 (Botulinum purified neurotoxin, Type A) Injection

Primary Outcome Measures

Name	Time	Method
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year	365 Days	The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.

Trial Locations

Locations (1)

ATS Clinical Research; 🇺🇸 Santa Monica, California, United States