Alastair Carruthers1, Suzanne Bruce, Arlette de Coninck, Simon Connolly, Sue Ellen Cox, Paula G Davis, Antoinette Campo, Xiaofang Lei, Christine Somogyi, Elisabeth Lee, Helen McLean, Frederick Beddingfield. 1. *Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; †Suzanne Bruce and Associates, PA, Houston, Texas; ‡Department of Dermatology, Vrije Universiteit Brussel, Brussels, Belgium; §The Private Clinic, Glasgow, United Kingdom; ‖Department of Dermatology, School of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina; ¶Aesthetic Solutions, Chapel Hill, North Carolina; #Scientific Communications and Information, Parsippany, New Jersey; **Allergan, Inc., Irvine, California; and ††Kythera Biopharmaceuticals Inc., Calabasas, California; and ‡‡Department of Medicine, Division of Dermatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.
Abstract
BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.
RCT Entities:
BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFLFWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.
Authors: Hema Sundaram; Massimo Signorini; Steven Liew; Ada R Trindade de Almeida; Yan Wu; André Vieira Braz; Steven Fagien; Greg J Goodman; Gary Monheit; Hervé Raspaldo Journal: Plast Reconstr Surg Date: 2016-03 Impact factor: 4.730
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: Koenraad De Boulle; Alastair Carruthers; Nowell Solish; Jean Carruthers; Wolfgang G Phillipp-Dormston; Steven Fagien; Sara Sangha; Michael Silberberg; Cheri Mao Journal: Plast Reconstr Surg Glob Open Date: 2020-03-20