Secondary Logo

Journal Logo

Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects

Results From 2 Identical Phase III Studies

Beer, Kenneth R. MD*; Shamban, Ava Theresa MD; Avelar, Rui L. MD; Gross, John E. MD§; Jonker, Anneke MSc

doi: 10.1097/DSS.0000000000001903
Original Article: PDF Only
Open
SDC
PAP

BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.

OBJECTIVE To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines.

MATERIALS AND METHODS Adult subjects (n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 3:1 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study.

RESULTS Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related.

CONCLUSION In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

*Department of Clinical Research, Research Institute of the Southeast, West Palm Beach, Florida

ATS Clinical Research, Santa Monica, California

Evolus, Inc., Newport Beach, California

§UCI Health, Orange, California

Medical Writing Associates, West Vancouver, BC

Address correspondence and reprint requests to: Kenneth R. Beer, MD, Department of Clinical Research, Research Institute of the Southeast, 1500 North Dixie Highway, Suite 305, West Palm Beach, Florida 33401-2717, or e-mail: kenbeer@aol.com

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.dermatologicsurgery.org).

A. T. Shamban and K. R. Beer served as principal clinical trial investigators for the EV-001 and EV-002 studies. All participating coinvestigators who formed the EV-001/EV-002 Study Group are listed in the acknowledgments. As sponsor of the EV-001 and EV-002 studies, Evolus, Inc., of Newport Beach, CA, was involved in the design of these studies and provided funding, study materials, equipment, and medications to all investigational sites. Evolus also provided funding to contract organizations involved in data collection, analysis, and reporting of the results. R. L. Avelar is the Head of R&D and Chief Medical Officer for Evolus, Inc., and receives compensation in salary, stock, and stock options. Before and during the time of these studies and manuscript preparation, J. E. Gross was the Chief Scientific Officer at Evolus, Inc.; he will receive royalty and milestone payments should the product be approved. Anneke Jonker of Medical Writing Associates, West Vancouver, BC, Canada, provided technical assistance with manuscript preparation and submission; she holds stock in Evolus, Inc.

© 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.