Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines

Abstract

BACKGROUND Understanding the subjects' perspective is critical for successfully treating upper facial lines. OBJECTIVE To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. METHODS This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed. RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo). CONCLUSION This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.

To click or not to click – The importance of understanding the layers of the forehead when injecting neuromodulators – A clinical, prospective, interventional, split‐face study

“…2,3 The most frequent areas targeted with neuromodulators include the forehead and the glabellar complex which has been shown to result in a younger overall facial appearance. 4 Recent anatomic research has reported on the bidirectional movement of the frontalis muscle providing evidence for two separate segments of this muscle: eyebrow elevator (lower forehead) vs hairline depressor (upper forehead). 5 To avoid eyebrow ptosis, the authors suggested injecting a reduced amount of neuromodulators in the eyebrow elevation segment of the frontalis muscle via a more superficial product administration.…”

“…The most frequent areas targeted with neuromodulators include the forehead and the glabellar complex which has been shown to result in a younger overall facial appearance 4 . Recent anatomic research has reported on the bidirectional movement of the frontalis muscle providing evidence for two separate segments of this muscle: eyebrow elevator (lower forehead) vs hairline depressor (upper forehead) 5 .…”

Facial Line Outcomes (FLO-11) and Facial Line Satisfaction Questionnaire (FLSQ) Meet FDA Patient-Reported Outcome Guidance

“…Recent publication of two 12-month, phase 3 studies of toxin-naive subjects receiving onabotulinumtoxinA or placebo for treatment of FHLs noted that the current versions of these questionnaires meet the FDA PRO guidance. 7 In these phase 3 studies, subject-reported satisfaction and impact of treatment were prespecified secondary endpoints collected from FLSQ and FLO-11. 7 Based on the evidence from these studies, the FDA approved FLSQ satisfaction data in the product labeling for onabotulinumtoxinA treatment of FHLs.…”

“… 7 In these phase 3 studies, subject-reported satisfaction and impact of treatment were prespecified secondary endpoints collected from FLSQ and FLO-11. 7 Based on the evidence from these studies, the FDA approved FLSQ satisfaction data in the product labeling for onabotulinumtoxinA treatment of FHLs. 7 …”

“… 7 Based on the evidence from these studies, the FDA approved FLSQ satisfaction data in the product labeling for onabotulinumtoxinA treatment of FHLs. 7 …”