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

NCT02334436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2019-03-27

Study results available
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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

Conditions

  • Glabellar Frown Lines

Interventions

BIOLOGICAL

Botulinum toxin, Type A

Botulinum toxin, Type A

OTHER

0.9% sterile, unpreserved saline

Placebo Comparator Arm

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Evolus, Inc.

    lead INDUSTRY

Principal Investigators

  • Rui Avelar, MD · Evolus, iInc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-09-30
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 NCT02334436 on ClinicalTrials.gov