Jean Carruthers1, Nowell Solish, Shannon Humphrey, Nathan Rosen, Channy Muhn, Vince Bertucci, Arthur Swift, Andrei Metelitsa, Roman G Rubio, Jacob Waugh, John Quiring, Gill Shears, Alastair Carruthers. 1. *Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; †Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; ‡Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; §Faculty of Medicine, McMaster University, Hamilton, Ontario, Canada; ‖Dermetics, Burlington, Ontario, Canada; ¶Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; #The Westmount Institute of Plastic Surgery, Montreal, Québec, Canada; **Division of Dermatology, University of Calgary, Calgary, Alberta, Canada; ††Revance Therapeutics, Inc., Newark, California; ‡‡QST Consultations, Ltd., Allendale, Michigan; §§Write on Target Ltd., Leighton Buzzard, United Kingdom; ‖‖Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Abstract
BACKGROUND:Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this 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 60UdaxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).
RCT Entities:
BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this 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. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).
Authors: Jean D Carruthers; Steve Fagien; John H Joseph; Shannon D Humphrey; Brian S Biesman; Conor J Gallagher; Yan Liu; Roman G Rubio Journal: Plast Reconstr Surg Date: 2020-01 Impact factor: 5.169
Authors: Cristina Pires Camargo; Jun Xia; Caroline S Costa; Rolf Gemperli; Maria Dc Tatini; Max K Bulsara; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2021-07-05
Authors: Joseph Jankovic; Daniel Truong; Atul T Patel; Allison Brashear; Marian Evatt; Roman G Rubio; Chad K Oh; Daniel Snyder; Gill Shears; Cynthia Comella Journal: Mov Disord Clin Pract Date: 2018-04-26
Authors: Jeremy B Green; Kavita Mariwalla; Kyle Coleman; Glynis Ablon; Susan H Weinkle; Conor J Gallagher; Domenico Vitarella; Roman G Rubio Journal: Dermatol Surg Date: 2021-01-01 Impact factor: 2.914