Efficacy of IncobotulinumtoxinA for the Treatment of Glabellar Frown Lines in Male Subjects: Post-Hoc Analyses From Randomized, Double-Blind Pivotal Studies

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Abstract

BACKGROUND

Males are increasingly seeking minimally invasive cosmetic procedures such as botulinum toxin injection. However, few studies have specifically examined the efficacy of such procedures among men.

OBJECTIVE

To assess the efficacy of incobotulinumtoxinA for treating glabellar frown lines (GFLs) in men.

METHODS

Three incobotulinumtoxinA studies were included in post hoc analyses of responder rates: 2 pivotal Phase 3 US registration studies for GFLs (n = 55 males in a pooled analysis) and a European pivotal Phase 3 study for upper facial lines (UFLs; n = 21 males).

RESULTS

In the pooled analysis of Phase 3 GFL studies, 55.9% of males and 81.4% of females were responders on the Facial Wrinkle Scale (FWS) at 30 days. Similarly, 54.5% and 88.0% of males and females, respectively, treated for GFLs in the upper facial line study were responders on the Merz Aesthetics Scales (MAS) at 30 days. Lower proportions of male responders on the Facial Wrinkle Scale /Merz Aesthetics Scales were consistent with results from onabotulinumtoxinA and abobotulinumtoxinA GFL studies.

CONCLUSION

Compared with females, males demonstrate lower response rates on wrinkle severity scales in studies on all 3 available botulinum toxins. Variations in treatment response are potentially associated with key male anatomic differences (e.g., muscle mass). Results emphasize the need for customized treatment plans.

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