Improvement of platysma prominence with onabotulinumtoxinA: Safety and efficacy results from a randomized, double-blinded, placebo-controlled phase 3 trial - 15/11/24

Doi : 10.1016/j.jaad.2024.10.027

Sabrina Fabi, MD ^a,^⁎ , Shannon Humphrey, MD ^b, Brian Biesman, MD ^c, Rosalyn George, MD ^d, Brenda LaTowsky, MD ^e, Robert A. Weiss, MD ^f, Grace S. Park, DrPH ^g, Sandhya Shimoga, PhD ^g, Elisabeth Lee, MBA, MPH ^h, Edward Jierjian, PharmD ^h, Warren Tong, PharmD ^h, René Hopfinger, MS ^h
^a Cosmetic Laser Dermatology, San Diego, California
^b Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada
^c Associate Clinical Professor Ophthalmology, Dermatology, Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee
^d Wilmington Dermatology Center, Howe Creek Landing, Wilmington, North Carolina
^e Clear Dermatology and Aesthetic Center, North Scottsdale, Arizona
^f Maryland Laser Skin and Vein, Hunt Valley, Maryland
^g AbbVie, Irvine, California
^h Allergan Aesthetics, An AbbVie Company, Irvine, California

^∗Correspondence to: Sabrina Fabi, MD, Cosmetic Laser Dermatology, 9339 Genesee Ave, Suite 350b, San Diego, CA 92121.Cosmetic Laser Dermatology9339 Genesee AveSuite 350bSan DiegoCA92121

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Friday 15 November 2024

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.

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

Abbreviations used : ANLFQ, BAS-PP, C-APPS, ITT, mITT, OnabotA, P-APPS, PP, TEAE

Esquema

Introduction

Methods

Study design

Randomization and blinding

	Funding sources: This study was funded by Allergan Aesthetics, an AbbVie company.
	Presented in part at American Academy of Dermatology 2024 (AAD; March 8-12, San Diego, California), 22nd Aesthetic & Anti-aging Medicine World Congress (AMWC; March 27-29, Monte Carlo, Monaco), Societa Italiana di Medicina Estetica - XLV Congresso Nazionale (SIME; May 10-12, Rome, Italy), NICE TOX fourth course (May 16-18, Nice, France).
	Patient consent: Consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors and included at the time of article submission to the journal stating that all patients gave consent with the understanding that this information may be publicly available.
	IRB approval status: This study complied with the Declaration of Helsinki, included written informed consent, and was approved by institutional review boards (Advarra IRB, Columbia, MD, USA, and Advarra IRB, Aurora, ON, Canada).
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