XEOMIN® is clinically proven to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Using criteria based on combined physician and patient reported response, XEOMIN® was proven to deliver significantly superior efficacy over placebo at Day 30 in two randomized, double-blind, multi-center clinical trials.1-3
The studies enrolled 547 healthy patients (=18 years old) with glabellar lines of at least moderate severity at maximum frown. Three hundred and sixty six subjects were treated with 20 Units of XEOMIN® and 181 subjects were treated with placebo. Subjects were excluded if they had marked ptosis, deep dermal scarring, or an inability to lessen glabellar lines, even by physically spreading them apart. XEOMIN® treated subjects ranged from 24 to 74 years of age with a mean age of 46.
Patients were classified as responders only if they had a 2-grade improvement on a 4-point scale compared to baseline, as assessed by both the investigator and subject. Using these criteria, the percentage of subjects with treatment success was greater on the XEOMIN® arm than the placebo arm at Day 30 in both studies.1-3
Table 1. Treatment Success at Day 301 (at least 2 grades of improvement from baseline at maximum frown)
|STUDY 1||STUDY 2|
|XEOMIN® (N=184)||Placebo (N=92)||XEOMIN® (N=182)||Placebo (N=89)|
|Composite treatment success*||111(60%)||0(0%)||87(48%)||0(0%)|
*Success on both the Investigator and Subject Assessments
In addition, the percentage of patients achieving investigator-rated scores of 0 (none) or 1 (mild) for glabellar lines at Day 30, at maximum frown, were 79.9% and 76.4% in the incobotulinumtoxinA groups in each study respectively, compared with 0.0% for placebo in both studies (p<0.0001 for both comparisons).1-3