Marion Moers-Carpi1, Jean Carruthers, Steven Fagien, Mary Lupo, Henry Delmar, Derek Jones, Christine Somogyi, Elisabeth Lee, Xiaofang Lei, Suzanne MacKinnon, Paula G Davis, Ramana Yalamanchili, Antoinette Campo, Frederick C Beddingfield. 1. *Private Clinic, Hautok, Munich, Germany; †Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada; ‡Private Practice, Boca Raton, Florida; §Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana; ‖Private Practice, New Orleans, Louisiana; ¶Centre de Chirurgie Esthétique du Cap d'Antibes, Cap d'Antibes, France; #Division of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; **Allergan, Inc., Irvine, California; ††SCI Scientific Communications and Information, Parsippany, New Jersey. Dr. Beddingfield and Ms. Somogyi are now at Kythera Biopharmaceuticals, Inc., Calabasas, California.
Abstract
BACKGROUND: This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL). METHODS: This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points 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). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain). CONCLUSION:OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.
RCT Entities:
BACKGROUND: This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL). METHODS: This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points 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). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain). CONCLUSION: OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.
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