Derek Jones1, Jean Carruthers, Rhoda S Narins, William P Coleman, Laura Harrington, Fredric S Brandt, Joel L Cohen. 1. *Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; †Carruthers Clinical Research, Vancouver, BC, Canada; ‡Dermatology Surgery and Laser Center, White Plains, New York; §Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana; ‖Ogilvy 4D, Oxford, United Kingdom; ¶Dermatology Research Institute, Coral Gables, Florida; #AboutSkin Dermatology and DermSurgery, Englewood, Colorado.
Abstract
BACKGROUND:Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions. OBJECTIVE: To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies. MATERIALS AND METHODS:IncobotulinumtoxinA and placebogroups comprised 366 and 181 subjects, respectively. The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates (≥ 1-point improvement from baseline), mean score, and mean change from the baseline glabellar frown line severity score. RESULTS: At all follow-up visits, responder rates and mean change from the baseline score (investigator-assessed and subject-assessed) were significantly greater for incobotulinumtoxinA versus placebo (p < .0001). The maximum investigator-assessed responder rate (93.1%) was achieved at Day 30 after treatment, when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88. Treatment effect declined over time but the investigator-assessed responder rate was 45.7% at the end of the study. CONCLUSION: Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed. IncobotulinumtoxinA achieved a maximum responder rate of 93.1% and a long duration of treatment effect: 45.7% of subjects showed efficacy at 120 days.
RCT Entities:
BACKGROUND: Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions. OBJECTIVE: To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies. MATERIALS AND METHODS: IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects, respectively. The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates (≥ 1-point improvement from baseline), mean score, and mean change from the baseline glabellar frown line severity score. RESULTS: At all follow-up visits, responder rates and mean change from the baseline score (investigator-assessed and subject-assessed) were significantly greater for incobotulinumtoxinA versus placebo (p < .0001). The maximum investigator-assessed responder rate (93.1%) was achieved at Day 30 after treatment, when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88. Treatment effect declined over time but the investigator-assessed responder rate was 45.7% at the end of the study. CONCLUSION: Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed. IncobotulinumtoxinA achieved a maximum responder rate of 93.1% and a long duration of treatment effect: 45.7% of subjects showed efficacy at 120 days.
Authors: Benjamin Ascher; Berthold Rzany; Philippe Kestemont; Said Hilton; Marc Heckmann; Isaac Bodokh; Ernst Magnus Noah; Dominique Boineau; Martina Kerscher; Magali Volteau; Philippe Le Berre; Philippe Picaut Journal: Aesthet Surg J Date: 2020-01-01 Impact factor: 4.283
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