OnabotulinumtoxinA for Treatment of Forehead and Glabellar Lines: Subject-Reported Satisfaction and Impact from a Phase 3 Double-Blind Study.

BACKGROUND Patient-reported outcomes are important measures of treatment benefit in facial aesthetic medicine. OBJECTIVE Evaluate prespecified subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment of forehead lines (FHL) and glabellar lines (GL). METHODS The study randomized (3: 1) 391 adults with moderate to severe FHL and GL to onabotulinumtoxinA (FHL, 20 U; GL, 20 U) or placebo in double-blind period 1 (days 0-180); subjects could receive up to 2 additional onabotulinumtoxinA treatments in open-label period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and the 11-item Facial Line Outcomes (FLO-11) Questionnaire. RESULTS The proportion of subjects mostly or very satisfied with treatment was significantly greater with onabotulinumtoxinA than with placebo (90.3% vs 1.0%; p <.0001). Responder rates on FLSQ Impact Domain (73.9% vs 18.9%), FLO-11 Item 1 (85.4% vs 3.6%), Item 4 (77.2% vs 11.2%), Item 5 (83.5% vs 7.8%), and total score (86.0% vs 6.9%) were significantly greater with onabotulinumtoxinA than with placebo on Day 30 (p <.0001). Responder rates favoring onabotulinumtoxinA in Period 1 were generally maintained with repeated treatment during Period 2. CONCLUSION Subjects were highly satisfied with onabotulinumtoxinA treatment and reported significant improvements in appearance-related psychological and emotional impacts of their facial lines.