Background
Despite evidence of a growing interest among men in minimally invasive cosmetic procedures such as botulinum toxin injections, comparator clinical trial data in this population are limited.
Objectives
To compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines.
Methods
Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20U prabotulinumtoxinA (n=25) or 20U onabotulinumtoxinA (n=31) in the EVB-003 single-dose Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1 point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale (GLS). Adverse events were also summarized.
Results
Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1 point improvement on the GLS at maximum frown were higher at all post-baseline time points for prabotulinumtoxinA-treated males (p>0.05 at all visits), by an absolute overall mean difference of 10.1% across all visit. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis.
Conclusions
The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across measures, differences between the two treatment groups did not reach statistical significance. Further study is warranted to establish whether observations based on these post-hoc analyses are reproducible in a larger male patient population.
Alluzience (abobotulinumtoxinA RTU, Galderma; Lausanne, Switzerland) is the first ready to use (RTU) botulinum toxin-type A liquid solution approved for the treatment of glabellar lines in Europe. In this article, the authors provide consensus recommendations on the aesthetic usage of abobotulinumtoxinA RTU. Members of the International Board on Alluzience (IBA) convened to develop consensus on the treatment of glabellar lines as well as other facial wrinkles based on their own extensive experience. Consensus recommendations were developed to provide practical guidelines for injection of abobotulinumtoxinA RTU. General guidance on proper assessment, treatment planning, and patient education is provided, as well as specific injection guidelines per indication. Indications covered include glabellar lines, crow’s feet, horizontal forehead lines, lateral eyebrow lift, lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, drooping mouth corners, masseter hypertrophy, hollow cheek lines, dimpled chin, and platysmal bands. These guidelines provide a practical framework to support routine injection of facial muscles with Alluzience.
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