A Two-Stage Injection Technique and Dose-Ranging Study Using High-Dose AbobotulinumtoxinA for Treating Platysmal Bands

January 2024 | Volume 23 | Issue 1 | 1311 | Copyright © January 2024


Published online December 15, 2023

doi:10.36849/JDD.7537

John H. Joseph MDa, Allen Foulad MDa,b, Victor B. Hsue MDc, Tahmineh Romero BSd, Patrick Davis MDb

aClinical Testing of Beverly Hills, Encino, CA
bFacial Plastic and Reconstructive Surgery, Beverly Hills, CA
cDivision of Otolaryngology – Head and Neck Surgery, Cedars-Sinai Medical Center, Los Angeles, CA
dUniversity of California, Los Angeles, Department of Medicine Statistics, Core, CA

Abstract
Background: AbobotulinumtoxinA (aboBoNT-A) is useful for the treatment of platysmal banding. This study evaluated the efficacy and safety of a standardized 2-staged injection technique using high doses of AboBoNT-A for treating platysmal banding.
Methods: This was a randomized, double-blinded, dose-ranging prospective study. Subjects included adults with moderate-to-severe platysmal bands (grade 3 or 4 on the validated 5-point photographic scale), who received either 120 U (Cohort 1) or 180 U (Cohort 2) of aboBoNT-A, followed by an optional 90 U touch-up. The relatively higher on-label concentration of aboBoNT-A was used (1.5 mL/300 units) to reduce the volume injected and the risk of spread to adjacent muscles. Subjects were followed for 5 months, with safety and efficacy endpoints evaluated by the Investigator Live Assessment (ILA) and Subject Live Assessment (SLA).
Results: Twenty women were included in the analysis. Cohort 1 and Cohort 2 had 100% and 90% responder rates (achieved grade 1 or 2) during maximal contraction at month 1 with ILA. Cohort 2 had more subjects with 2 or greater grade improvement at maximal contraction using both ILA and SLA. Cohort 2 also had longer time to loss of grade 1 or 2 at maximal contraction compared with Cohort 1. No major adverse reactions occurred, but 3 subjects experienced transient positional neck weakness.
Conclusion: We demonstrate a standardized 2-stage injection technique using aboBoNT-A for effectively treating moderate-to-severe platysmal banding. We used relatively higher doses while maintaining a good safety profile by using the more concentrated on-label volume of reconstitution for aboBoNT-A and by including a touch-up.

J Drugs Dermatol. 2024;23(1):1311-1318.     doi:10.36849/JDD.7537

INTRODUCTION

Botulinumtoxin type A (BoNT-A) injections are the most popular cosmetic procedure in the world.1 By blocking acetylcholine neurotransmitter presynaptic release, this neurotoxin can reduce muscle contraction and lead to functional benefits in spasticity and cosmetic effects in minimizing wrinkles. There are several different preparations of BoNT-A available for aesthetic use worldwide, each with different manufacturing processes and properties.

AbobotulinumtoxinA (aboBoNT-A; Dysport, Ipsen Biopharm Ltd., Wrexham, UK; Azzalure, Galderma Ltd., Lausanne, Switzerland) is currently approved in the United States of America for treating moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients younger than 65 years of age for aesthetic purposes.2 The current US Food and Drug Administration (FDA)-recommended dosing is 50 U injected intramuscularly in 5 equal aliquots of 10 U each using a reconstitution involving 2.5 mL saline added to a 300 U vial. A reconstitution involving 1.5 mL saline added to a 300 U vial is also used on-label. 

aboBoNT-A is commonly used to treat wrinkles and lines in other areas of the face, neck, and chest for cosmetic purposes in an off-label manner.3 One area of increasing interest is treating the platysma as an effective non-surgical option for reducing platysmal bands and for improving jawline and neck contour. Treatment of the platysma with onabotulinumtoxinA (onaBoNT-A; Botox, Allergan, Irvine, CA, USA) has been well studied, and the mean dose for injection typically ranges between 10 U and 50 U.4 

Several total face rejuvenation studies have included treating the platysma with aboBoNT-A, using doses ranging from 40 U to 180 U and concentrations of 10 U to 12 U per 0.1 mL.4-8 A study by Jabbour et al evaluated the "Nefertiti Lift," which focused on injecting aboBoNT-A into platysmal bands and along a line below the inferior mandibular border.9 Each injection involved 5 U of aboBoNT-A, which had been reconstituted to a concentration of 20 U per 0.1 mL. The maximum dose allowed was 125 U and the mean dose used was 114.3 U. A touch-up treatment was performed using the same protocol for any