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Dermatol Surg. 2019 Mar 18. doi: 10.1097/DSS.0000000000001903. [Epub ahead of print]

Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies.

Author information

1
Department of Clinical Research, Research Institute of the Southeast, West Palm Beach, Florida.
2
ATS Clinical Research, Santa Monica, California.
3
Evolus, Inc., Newport Beach, California.
4
UCI Health, Orange, California.
5
Medical Writing Associates, West Vancouver, BC.

Abstract

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.

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