An analysis of the long-term safety data of repeat administrations of botulinum neurotoxin type A-ABO for the treatment of glabellar lines

Aesthetic Surgery Journal
Joel L CohenReloxin Investigational Group

Abstract

A new formulation of botulinum neurotoxin type A (BoNTA-ABO; Dysport [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ) was recently approved by the US Food and Drug Administration for the treatment of moderate to severe glabellar lines. To assess the long-term safety of repeat administrations of BoNTA-ABO for the treatment of glabellar lines, including variable dosing. This report summarizes an interim analysis that does not address the efficacy profile. Over 24 months, 1415 subjects underwent open-label retreatment with BoNTA-ABO. Patients were retreated with 50 units or a variable dose of 50, 60, 70, or 80 units based on gender and muscle mass. Dose was divided among five points in the glabellar region. Retreatments were performed if at least 85 days had elapsed between treatments and the glabellar line severity score was reassessed as moderate or severe. Patients were followed up at seven, 14, and 30 days postinjection, then monthly. Endpoints were adverse events (AE). Of 1415 patients, 932 (66%) experienced at least one AE. The rate of treatment-emergent AE (TEAE) was similar in both the fixed- and variable-dose groups. Most TEAE were rated mild (70%) or moderate (20%). The majority (87%; 3361/3861) of all TEAE inst...Continue Reading

Citations

Jan 1, 2014·Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.]·Joel SchlessingerUNKNOWN Dysport Study Group
Aug 30, 2012·Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.]·Susan C TaylorXiaoming Lin
Jun 16, 2011·Clinical, Cosmetic and Investigational Dermatology·Uwe Wollina, Alberto Goldman
Oct 9, 2013·Journal of the American Academy of Dermatology·C William HankeLuitgard G Wiest
Mar 1, 2012·Journal of Cosmetic Dermatology·Timothy Corcoran Flynn
Mar 27, 2013·Aesthetic Surgery Journal·Z Paul LorencHeidi A Waldorf
Apr 8, 2017·Aesthetic Surgery Journal·Joel L Cohen, Nicolo Scuderi
Sep 29, 2018·British Dental Journal·S N DelpachitraM Dastaran
Nov 10, 2020·Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.]·Hyemin PomerantzRoy G Geronemus
Apr 7, 2021·Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete·A PatilM Goldust
Oct 15, 2020·Aesthetic Plastic Surgery·Nitin SethiEqram Rahman
Aug 12, 2021·Journal of Cosmetic Dermatology·Mark S NestorRoberto Polselli

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