NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials

William Coleman; Vince Bertucci; Shannon Humphrey; Joely Kaufman-Janette; Terrence Keaney; David Pariser; Nowell Solish; David Wirta; Robert A Weiss

doi:10.1093/asj/sjae233

NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials

Aesthet Surg J. 2024 Nov 26:sjae233. doi: 10.1093/asj/sjae233. Online ahead of print.

Authors

William Coleman¹, Vince Bertucci², Shannon Humphrey³, Joely Kaufman-Janette⁴, Terrence Keaney⁵, David Pariser⁶, Nowell Solish⁷, David Wirta⁸, Robert A Weiss⁹

Affiliations

¹ Dermatologic surgeon in private practice, Metairie, LA. USA.
² Dermatologist in private practice, Woodbridge, ON, Canada.
³ Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.
⁴ Dermatologist in private practice, Coral Gables, FL, USA.
⁵ Dermatologist in private practice, Arlington, VA, USA.
⁶ Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA.
⁷ Department of Dermatology, University of Toronto, Toronto, ON, Canada.
⁸ Oculoplastic surgeon in private practice, Newport Beach, CA, USA.
⁹ Dermatologist in private practice, Hunt Valley, MD, USA.

PMID: 39587780
DOI: 10.1093/asj/sjae233

Abstract

Background: Botulinum neurotoxins used in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors.

Objectives: Evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with/without treatment of lateral canthal lines (LCL).

Methods: Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL+LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20U (GL), nivobotulinumtoxinA 44U (GL+LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving ≥2-grade improvement in Facial Wrinkle Scale (FWS) at maximum frown on investigator and participant assessment; co-primary endpoints were investigator- and participant-assessed FWS "none or mild" rating.

Results: At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL+LCL (Study 005, 41.3%) versus placebo (0%; all P < 0.001). Responder rates of "none or mild" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL+LCL (Study 005, 74.0% and 61.2%) versus placebo (all P < 0.001). Adverse events were similar between treatment groups and placebo.

Conclusions: Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL.

© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].