Improvement of platysma prominence with onabotulinumtoxinA: Safety and efficacy results from a randomized, double-blinded, placebo-controlled phase 3 trial
Sabrina G. Fabi, Shannon Humphrey, Brian S. Biesman, Rosalyn George, Brenda LaTowsky, Robert A. Weiss, Grace S. Park, Sandhya Shimoga, Elisabeth Lee, Edward Jierjian, Warren Tong, René Hopfinger
Abstract
BACKGROUND: Platysma prominence (PP) refers to the undesirable effects that may occur with platysma muscle contraction. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for improving Moderate (Grade 3) to Severe (Grade 4) PP in adults. METHODS: Participants were randomized 1:1 to receive a total dose of onabotulinumtoxinA 26, 31, or 36 U or placebo on Day 1 and monitored for 120 days. Dosage was administered via superficial intramuscular injections into the platysma muscle based on baseline PP severity. RESULTS: At Day 14, 32.3% of onabotulinumtoxinA-treated participants in the intent-to-treat population versus 1.9% who received placebo achieved investigator- and participant-rated Grade 1 or 2 (Minimal or Mild) and ≥2-grade improvement from baseline in PP severity, while 56.9% and 51.7% achieved Grade 1 or 2 on investigator's and participant's assessments, respectively (all P < .0001). OnabotulinumtoxinA-treated participants reported higher satisfaction, less bother from jawline and vertical neck band appearance, and reduced psychosocial impact versus placebo (all P < .0001). Adverse event incidence was similar between onabotulinumtoxinA and placebo. No events of dysphagia or muscular weakness were reported. LIMITATIONS: A single onabotulinumtoxinA treatment was evaluated. CONCLUSION: OnabotulinumtoxinA showed favorable tolerability and significantly improved PP severity and patient-reported outcomes in participants with moderate-to-severe PP.