Multicenter, randomized, parallel-group study of onabotulinumtoxinA and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation: satisfaction and patient-reported outcomes

Abstract

Background: Patient-reported outcomes (PROs) are important assessment benchmarks after aesthetic procedures. Systematic studies of PROs have not been conducted in the lower face.

Objective: To study satisfaction and other PROs after treatment of the lower face with onabotulinumtoxinA and a 24-mg/mL smooth, cohesive hyaluronic acid (HA) gel filler, alone or in combination.

Methods: Ninety female participants aged 35 to 55 were randomized to one of three groups: 24-mg/mL cohesive gel alone (n=30), onabotulinumtoxinA alone (n=30), or the combination (n=30). Effectiveness outcomes were investigator- and participant-rated satisfaction and the participant Self-Perception of Age (SPA) and participant-rated Look and Feel of the Lips and Mouth (LAF) questionnaires. Participants maintained a 14-day diary to record severity of treatment site responses.

Results: All treatments resulted in significant improvements from baseline at all end points and on all PRO measures. For all measures and most time points, the 24-mg/mL cohesive gel treatment groups experienced greater improvements than onabotulinumtoxinA alone. Participant-rated severity of treatment-related reactions was mainly mild and transient.

Conclusion: OnabotulinumtoxinA and 24-mg/mL cohesive HA gel treatments, used alone or in combination for lower face rejuvenation, resulted in significant improvement in investigator- and participant-reported outcomes.