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

NCT02184988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2019-04-24

Study results available
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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.

Conditions

  • Glabellar Frown Lines

Interventions

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.

Sponsors & Collaborators

  • Evolus, Inc.

    lead INDUSTRY

Principal Investigators

  • Rui Avelar, MD · Evolus, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184988 on ClinicalTrials.gov