Абстракт

Objectives: To compare the efficacy and safety of the injectable neuromodulator, prabotulinumtoxinA, for the treatment of moderate to severe glabellar lines between millennial (born 1982-2000, n=65) and non-millennial (born ≤1981, n=668) patients who participated in the three single-dose Phase III glabellar line clinical studies. Importantly, both cohorts were similarly matched at baseline in the severity of their glabellar lines at maximum frown, as measured on the 4-point Glabellar Line Scale (GLS: 0=none, 1=mild, 2=moderate, 3=severe). Introduction: Millennials, as defined by the US Census Bureau, were born between 1982 and 2000. Millennial use of aesthetic products is increasing – particularly of those products that are both minimally invasive and can be used preventatively. At the same time, there is a paucity of published clinical trial data in this population. Materials / method: Post-hoc analyses were performed on the pooled population of all 733 patients treated with 20U prabotulinumtoxinA in the single-dose studies. At the time that these studies were conducted (Jan-Nov 2015), millennial patients were 21-33 years and non-millennial patients were 33-81 years. One of the main efficacy endpoints was the proportion of responders with a ≥1 point improvement from baseline at maximum frown on the 4-point GLS. Global aesthetic improvement and subject satisfaction were also assessed, and treatment-related adverse events of particular interest were summarized. Results: The proportion of millennial responders with a ≥1 point improvement from baseline on the GLS at maximum frown was greater than that of non-millennials by 7.7% on average across all visits. Differences were statistically significant on Day 90, with responder rates of 90.2% and 76.1%, respectively (p=0.01). Similar trends were observed for global aesthetic improvement and subject satisfaction. Treatment-related headache was observed in 9.0% of millennials and 9.4% of non-millennials; treatment-related eyelid ptosis was observed in 1.5% of millennials and 1.2% of non-millennials. Conclusion: As evident in these post-hoc analyses, despite similarities in the severity of glabellar lines at maximum frown at baseline, a single dose of 20U prabotulinumtoxinA administered for the treatment of moderate to severe glabellar lines was consistently more efficacious in millennials than non-millennials. Satisfaction among millennials remained very high throughout the study. The treatment was similarly well-tolerated by both cohorts.