Treatment Satisfaction, Improvements in Jawline Definition, and Psychosocial Impact With OnabotulinumtoxinA for Platysma Prominence: Patient-Reported Outcomes From 2 Multicenter, Randomized, Placebo-Controlled Phase 3 Studies.

Abstract

Individuals with prominence of the platysma muscle resulting from visible vertical neck bands and loss of jawline definition may experience negative impacts on both their quality of life and psychological well-being. Two pivotal Phase 3 clinical trials showed that a single treatment of onabotulinumtoxinA (onabotA) reduced the severity of platysma prominence (PP) and was well tolerated by participants. The aim of this study was to report the participants' experiences of onabotA treatment for PP compared with placebo based on validated patient-reported outcomes (PROs). Pooled analysis from 2 Phase 3, pivotal clinical trials utilized PROs to assess patient-perceived outcomes of treatment. Participants with moderate-to-severe PP were randomized 1:1 to onabotA (26, 31, or 36 U) or placebo. De novo, fit-for purpose PRO measures, validated per FDA guidance, were used to evaluate treatment satisfaction, bother with vertical neck bands and jawline, psychosocial impacts of PP, and improvement and satisfaction with jawline definition. Treatment with onabotA resulted in improvements across all PRO measures at Day 14, including satisfaction with treatment (onabotA, 64.0% vs placebo, 11.5%) and with jawline (onabotA, 43.3%; placebo, 10.4%), reduced bother with jawline definition (onabotA, 51.1%; placebo, 11.0%) and vertical neck bands (onabotA, 52.0%; placebo, 19.0%); and reduced psychosocial impact because of PP. The treatment benefits were sustained throughout the study period. OnabotA treatment results in high treatment satisfaction, improves jawline definition, and reduces negative impacts, including appearance-related psychosocial impacts, because of PP and bother from vertical neck bands and jawline in participants with moderate-to-severe PP.