Multicenter, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines
ABSTRACT BACKGROUND: Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins. OBJECTIVE: To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration-mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120. RESULTS: Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated. CONCLUSION: A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.
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ABSTRACT: Three botulinum neurotoxin type A preparations (incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA) are widely approved in Europe and in the US for the treatment of glabellar frown lines. The purpose of this study was to determine and compare the time to onset and duration of treatment effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA for the treatment of glabellar frown lines. Subjects aged 20-60 years with moderate to severe glabellar frown lines received one treatment of either 21 units (U) incobotulinumtoxinA, 21 U onabotulinumtoxinA, or 63 U abobotulinumtoxinA. Assessments were made over a period of 180 days. Onset of treatment effect was defined as the day that the observer noted a decrease in glabellar muscle activity compared with baseline photographs and videos. Duration of treatment effect was defined as the time until glabellar muscle action returned to the baseline level. Analyses were performed using a Weibull log(T) regression model. The study enrolled 180 subjects; 60 per group. For all three products, onset of treatment effect occurred earlier in female subjects compared to male subjects. For both sexes, a significantly earlier time to onset of treatment effect was seen for incobotulinumtoxinA compared to onabotulinumtoxinA and abobotulinumtoxinA; in female subjects these times were 3.02 days, 5.29 days, and 5.32 days, respectively. The duration of treatment effect was longer for incobotulinumtoxinA compared to onabotulinumtoxinA and abobotulinumtoxinA; for all products, treatment effect duration was longer in females than in males. Time to onset was not a predictor of treatment duration. IncobotulinumtoxinA demonstrated a more rapid onset and a longer duration of treatment effect than onabotulinumtoxinA (1:1 dose ratio) and abobotulinumtoxinA (1:3 dose ratio). Onset of effect was faster and duration of effect was longer in female subjects compared to male subjects.Clinical, Cosmetic and Investigational Dermatology 09/2013; 6:211-219. DOI:10.2147/CCID.S41537
Dermatologic Surgery 05/2013; 39(7). DOI:10.1111/dsu.12101 · 1.56 Impact Factor
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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 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.RESULTSAt 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.Dermatologic Surgery 07/2014; 40(7):776-785. DOI:10.1111/dsu.0000000000000001 · 1.56 Impact Factor