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Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study

Bertucci, Vince MD*; Humphrey, Shannon MD; Carruthers, Jean MD; Solish, Nowell MD*; Muhn, Channy MD§,‖; Swift, Arthur MD; Rubio, Roman G. MD#; Shears, Gill PhD**; Rosen, Nathan MD§,‖

doi: 10.1097/DSS.0000000000001364
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BACKGROUND Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002).

OBJECTIVE To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity.

MATERIALS AND METHODS In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks.

RESULTS Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup.

CONCLUSION 40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines—with a greater advantage observed in severe glabellar lines.

*Division of Dermatology, University of Toronto, Toronto, Ontario, Canada;

Departments of Dermatology and Skin Science, and

Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada;

§Faculty of Medicine, McMaster University, Hamilton, Ontario, Canada;

Dermetics, Burlington, Ontario, Canada;

The Westmount Institute of Plastic Surgery, Montreal, Québec, Canada;

#Clinical Development Department, Revance Therapeutics, Inc., Newark, California;

**Write on Target Ltd., Leighton Buzzard, United Kingdom

Address correspondence and reprint requests to: Vince Bertucci, MD, Division of Dermatology, University of Toronto, 100-8333 Weston Road, Woodbridge, Ontario L4L 8E2 Canada, or e-mail: vince.bertucci@utoronto.ca

This study and the post hoc analyses were funded by Revance Therapeutics, Inc. DaxibotulinumtoxinA is an investigational agent. V. Bertucci is an investigator, consultant and/or speaker for Allergan, Evolus, Galderma, Merz and Revance. S. Humphrey is an investigator, consultant and/or speaker for Allergan, Galderma, Revance, Merz, Evolus, and Zeltiq. J. Carruthers is a consultant and researcher for Revance, Allergan, Merz, Alphaeon, and Zeltiq. She has received grant money, consulting fees/honoraria, support for travel to meetings, and writing assistance, medicines, equipment, or administrative support. N. Solish is in receipt of a grant from Revance for participating in this study, and is a consultant to Revance, Allergan, and Galderma. A. Swift is in receipt of an investigator fee from Revance Therapeutics, Inc. R.G. Rubio is an employee of, and holder of stock/stock options in, Revance Therapeutics, Inc. G. Shears is an employee of Write on Target Ltd., which has received fees from Revance Therapeutics, Inc. for medical writing services. N. Rosen is an investigator, consultant and/or speaker for Allergan, Galderma, Merz, and Revance. The remaining author has indicated no significant interest with commercial supporters.

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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