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

Abstract

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.

Long-term Effects of Repeated Botulinum Toxin Injection in Cosmetic Therapeutics

“…3,4,6,[10][11][12][13][14]16,33 Only a few studies excluded patients who had received previous BT-A injections. 12,15,48 Study aims varied from evaluating the efficacy and longevity of BT-A injections in cosmetic use, to adjunctive uses, to comparisons of various formulations of BT-A. Many studies received commercial support from pharmaceutical companies manufacturing a specific toxin preparation.…”

“…Earlier studies 7,9 had sparse details on study design, making results comparison difficult, if not impossible. Most studies showed that BT-A injections carried a lasting result beyond 4 months 5,7,[11][12][13][14]16 posttreatment, extending to 3 to 4 years in some cases. 6,8 The studies also included comparisons of different preparations and dilutions.…”

“…Of the 14 clinical studies, 10 were clearly randomized trials 3,4,6,10–14,16,33 . Only a few studies excluded patients who had received previous BT-A injections 12,15,48 .…”

“…[45][46][47][48][49] Authors were unable to obtain access to 1 publication through their institutions. 50 The remaining 22 publications were included in our review, [3][4][5][6][7][8][9][10][11][12][13][14][15][16]31,[34][35][36][37][38][39][40] and of these, 8 were reviews 31,[34][35][36][37][38][39][40] and 14 were clinical studies [3][4][5][6][7][8][9][10][11][12][13][14][15][16] (Table 1).…”

Treatment of crow’s feet lines and forehead lines with Botox (onabotulinumtoxinA): Development, insights, and impact

“…Allergan also extensively monitored for immunogenicity in North American, European, and Asian patient populations, with no positive neutralizing antibody results among patients receiving up to 5 treatments of onabotulinumtoxinA. In all, Allergan conducted 8 registration studies (6 phase 3 and 2 phase 2 studies) for CFL, [8,14,16,[26][27][28][29][30] including several specifically designed for Japan and China. [28,30] Based on the neurologic exam and immunogenicity data generated from the CFL program, these assessments were not required for the subsequent FHL registration studies.…”