Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?

December 2016 | Volume 15 | Issue 12 | Original Article | 1544 | Copyright © 2016

John H. Joseph MD,a Laura L. Eaton RN BSN,b James Robinson MS,c Allison Pontius MD,d and Edwin F.Williams III MDd

aClinical Testing of Beverly Hills, CA bUltaMed Corporation, Fort Lauderdale, FL cSimulstat Inc., San Diego, CA dWilliams Center for Plastic Surgery, Latham, NY

Abstract

OBJECTIVE: To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines. DESIGN: Investigator-initiated, prospective, multi-center, open-label study. Material and Methods: This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex. Investigator and subject assessments of wrinkle severity at maximum frown and repose using 4-point scales and adverse events were conducted. Follow-up was monthly for up to 11 months. RESULTS: The median duration of response for all subjects, as assessed by the investigator, was 150 days (95% CI: 120, 180). The median duration of response was 165 days (95% CI: 90, 180) for subjects with Grade 2 (Moderate) wrinkles at baseline and 75 days (95% CI: 30, 120) for subjects with Grade 3 (Severe) wrinkles at baseline. Overall, 76.7% of subjects had a duration of ≥ 120 days. At the end of study (day 300) 9/16 (53%) of subjects who were Grade 3 at baseline still rated themselves as not returning to Grade 3, demonstrating ongoing improvement. Adverse events were mild and transient. There were no events of lid or brow ptosis. CONCLUSIONS: The 120 units of abobotulinumtoxinA were significantly effective in reducing glabellar lines in subjects with Grade 2 (Moderate) wrinkles at baseline for a longer duration than the reported 85 days in the FDA Phase III randomized, placebo-controlled clinical studies using a standard 50 unit dose. Subject satisfaction was high. There was no increase in the incidence of adverse events with this higher dose. J Drugs Dermatol. 2016;15(12):1544-1549.

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INTRODUCTION

Facial rhytids represent a widespread aesthetic concern.1 In particular, glabellar lines are perceived as a sign of aging and may give an erroneous impression of negative emotions.1 Clinicians and their patients recognize the important role, both negative and positive, that facial expression, particularly the glabellar frown lines, plays in self-perception, emotional well-being, and perception by others.2 Botulinum toxin type A treatment has been the foundation of minimally invasive treatment for aesthetic facial procedures2 and represented the top minimally invasive plastic surgery procedure in 2014, with 6.7 million procedures performed.3 AbobotulinumtoxinA (Dysport®, Galderma Laboratories, Ft. Worth, TX) was approved by the United States Food and Drug Administration (FDA) in 2009 as the second botulinum neurotoxin type A (BoNTA) for use in facial aesthetics.4 The approved indication for use is for temporary improvement in the appearance of;moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients 5 To achieve clinical effect, the current dosing guideline is a total of 50 units given intramuscularly in five equal aliquots of 10 units each into each of five sites, two in each corrugator muscle, and one in the procerus muscle.5 Additionally, retreatment is permitted every three months.5 To support the FDA approval, three double-blind, randomized, placebo-controlled, clinical studies evaluated the efficacy of Dysport for use in the temporary improvement of the appearance of moderate to severe glabellar lines.5 Baumann conducted an analysis of efficacy data from four phase III studies of Dysport in 2009. The median duration of response to 50 units was 85 days.6 Current FDA-approved botulinum toxin type A preparations share many characteristics in common, such as a clear safety

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