Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study.

[BACKGROUND] Repetitive contractions of the platysma muscle may result in vertical neck bands that blunt the jawline (i.e., platysma prominence [PP]). We report patient-reported outcomes (PROs) from a phase 2 study evaluating onabotulinumtoxinA (onabotA) for moderate or severe PP.

[METHODS] Subjects were randomized 1:1:1 to onabotA dose 1 (26 U, 31 U, or 36 U), onabotA dose 2 (52 U, 62 U, or 72 U), or placebo. De novo, validated, fit-for-purpose PROs were used to assess treatment satisfaction, bother with vertical neck bands and jawline, jawline definition, and psychosocial impact.

[RESULTS] Subjects with PRO data (N = 164; mean age, 50.0 years) were predominantly female (95.1%) and White (93.9%). Response rates for improvement in both onabotA dose groups were higher than placebo for treatment satisfaction, bother with vertical neck bands and jawline, as well as jawline definition (unadjusted p < 0.05 for all). Greater improvements in treatment satisfaction and psychosocial impact were observed in both dose groups versus placebo based on the mean total scores on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction and the mean change from baseline in ANLFQ: Impacts total score, respectively (unadjusted p < 0.0001 for all). Response rates generally peaked across all measures at day 14 or 30 for both dose groups, with a trend in improvement continuing through day 120.

[CONCLUSIONS] Compared with placebo, both onabotA dose groups reported greater satisfaction with the effect of treatment, improvements in jawline definition and psychological impact, as well as reductions in bother due to vertical neck bands and jawline.

[TRIAL REGISTRATION] ClinicalTrials.gov: NCT03915067.