Michael A C Kane1, Michael H Gold, William P Coleman, Derek H Jones, Emil A Tanghetti, Tina S Alster, Tom E Rohrer, Cheryl M Burgess, Ava T Shamban, Eleanor Finn. 1. *Manhattan Eye, Ear & Throat Hospital, New York, New York; †Tennessee Clinical Research Center, Nashville, Tennessee; ‡Tulane Health Sciences Center, New Orleans, Louisiana; §Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; ‖Center for Dermatology and Laser Surgery, Sacramento, California; ¶Washington Institute of Dermatologic Laser Surgery, Georgetown University Hospital, Washington, DC; #Skin Care Physicians, Chestnut Hill, Massachusetts; **Center for Dermatology and Dermatologic Surgery, Washington, DC; ††University of California Los Angeles, Los Angeles, California; ‡‡Complete Medical Communications, Macclesfield, United Kingdom.
Abstract
BACKGROUND:IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL. OBJECTIVE: To investigate the dose equivalence of incobotulinumtoxinA (20 U) and onabotulinumtoxinA (20 U) for the treatment of moderate-to-severe GFL. MATERIALS AND METHODS: Prospective, randomized (1:1), double-blinded, parallel-group study in 250 females (18-50 years), employing a single treatment withincobotulinumtoxinA or onabotulinumtoxinA, followed by a 4-month observational period. RESULTS: At the primary efficacy endpoint (1 month after treatment), incobotulinumtoxinA was equivalent to onabotulinumtoxinA in the treatment of GFL at the 20 U dose within the prespecified ± 15% margin of equivalence. Efficacy remained similar between treatment groups through 4 months after treatment as assessed by the independent masked panel and the masked treating physicians. Patient satisfaction ratings were similar between groups and favorable (>90%) throughout. Both treatments were well tolerated. CONCLUSION: Equivalence was demonstrated at the primary endpoint between incobotulinumtoxinA and onabotulinumtoxinA in the treatment of GFL at the 20 U dose at 1 month. Similar efficacy and tolerability profiles were observed through 4 months after treatment.
RCT Entities:
BACKGROUND: IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL. OBJECTIVE: To investigate the dose equivalence of incobotulinumtoxinA (20 U) and onabotulinumtoxinA (20 U) for the treatment of moderate-to-severe GFL. MATERIALS AND METHODS: Prospective, randomized (1:1), double-blinded, parallel-group study in 250 females (18-50 years), employing a single treatment with incobotulinumtoxinA or onabotulinumtoxinA, followed by a 4-month observational period. RESULTS: At the primary efficacy endpoint (1 month after treatment), incobotulinumtoxinA was equivalent to onabotulinumtoxinA in the treatment of GFL at the 20 U dose within the prespecified ± 15% margin of equivalence. Efficacy remained similar between treatment groups through 4 months after treatment as assessed by the independent masked panel and the masked treating physicians. Patient satisfaction ratings were similar between groups and favorable (>90%) throughout. Both treatments were well tolerated. CONCLUSION: Equivalence was demonstrated at the primary endpoint between incobotulinumtoxinA and onabotulinumtoxinA in the treatment of GFL at the 20 U dose at 1 month. Similar efficacy and tolerability profiles were observed through 4 months after treatment.
Authors: Javier Anido; Daniel Arenas; Cristina Arruabarrena; Alfonso Domínguez-Gil; Carlos Fajardo; Mar Mira; Javier Murillo; Natalia Ribé; Helga Rivera; Sofia Ruiz Del Cueto; Helder Silvestre; Marisa Tirado Journal: Clin Cosmet Investig Dermatol Date: 2017-10-19
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: David Rupp; Greg Nicholson; David Canty; Joanne Wang; Catherine Rhéaume; Linh Le; Lance E Steward; Mark Washburn; Birgitte P Jacky; Ron S Broide; Wolfgang G Philipp-Dormston; Mitchell F Brin; Amy Brideau-Andersen Journal: Toxins (Basel) Date: 2020-06-13 Impact factor: 4.546