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Clinical Trial
. 2025 Feb;92(2):285-291.
doi: 10.1016/j.jaad.2024.10.027. Epub 2024 Oct 21.

Improvement of platysma prominence with onabotulinumtoxinA: Safety and efficacy results from a randomized, double-blinded, placebo-controlled phase 3 trial

Sabrina Fabi  1 , Shannon Humphrey  2 , Brian Biesman  3 , Rosalyn George  4 , Brenda LaTowsky  5 , Robert A Weiss  6 , Grace S Park  7 , Sandhya Shimoga  7 , Elisabeth Lee  8 , Edward Jierjian  8 , Warren Tong  8 , René Hopfinger  8
Affiliations
Free article
Clinical Trial

Improvement of platysma prominence with onabotulinumtoxinA: Safety and efficacy results from a randomized, double-blinded, placebo-controlled phase 3 trial

Sabrina Fabi et al. J Am Acad Dermatol. 2025 Feb.
Free article

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.

Keywords: botulinum toxins, type A; intramuscular injection; jawline; lower face; neck; patient satisfaction; platysma muscle; platysma prominence; randomized controlled trial; rejuvenation; vertical neck bands.

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Conflict of interest statement

Conflicts of interest Financial arrangements of the authors with companies whose products may be related to the present report are listed as declared by the authors. Dr Fabi is a consultant/speaker for AbbVie, Galderma, Merz Aesthetics, Revance, CROMA, and Ortho Dermatologics; has received research support from AbbVie, Galderma, Merz, Revance, CROMA, and Raziel; and holds stock in AbbVie and Revance Therapeutics. Drs Biesman and George are speakers, consultants, investigators, and advisory board members for Allergan Aesthetics, an AbbVie company. Dr Humphrey is a speaker, consultant, and/or investigator for Allergan Aesthetics, an AbbVie company, Galderma, Merz, and Revance. Drs LaTowsky and Weiss are speakers, consultants, investigators, and advisory board members for Allergan Aesthetics, an AbbVie company, and Galderma. Drs Park and Shimoga are employees of AbbVie and may own AbbVie stock. Ms Lee, Mr Jierjian, Mr Tong, and Ms Hopfinger are employees of Allergan Aesthetics, an AbbVie company, and may own AbbVie stock.

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