Quantifiable Changes in the Submental Area and Mandible Border After Dual-Modality Treatment With ATX-101 and VYC-20L for Overall Improvement in Jawline Contour

January 2024 | Volume 23 | Issue 1 | 1325 | Copyright © January 2024


Published online December 13, 2023

doi:10.36849/JDD.7458

Greg J. Goodman MBBS MD FACDa, Stefania Roberts MBBS FRACGPb, Natasha Cook MBBS (hons) MD FACDc, Mark Ashton MBBS MD FRACSd, Rong Nie MSe, Lucille Alker RN MSNe, Michael Silberberg MD MBAf

aMonash University, Clayton, VIC, Australia
bVictoria Vein Clinic, East Melbourne, Australia
cDarlinghurst Dermatology Skin & Laser Clinic, Darlinghurst, Australia
dUniversity of Melbourne, Department of Surgery, Melbourne, Australia
eAbbVie, Irvine, CA
fAllergan Aesthetics, an AbbVie Company, Marlow, United Kingdom

Abstract
Background: A phase 4, prospective, open-label, multicenter study showed that treatment with deoxycholic acid injections (ATX-10) followed by a hyaluronic acid filler (VYC-20L) is safe and effective for reducing submental fullness and improving jawline definition.
Objective: To quantify changes in the jawline and submental area using 3-dimensional (3D) photogrammetry and conduct an immunohistochemical analysis of submental tissue. 
Methods: Participants received 1 to 6 ATX-101 treatments (8 weeks apart) followed by VYC-20L (optional touch-up after 14 days). Changes from baseline in jawline and submental volumes, submental major and minor strain events, submental skin displacement, and submental angles were quantified using photogrammetry. Submental skin biopsies (N=13) were excised for histologic analysis. Treatment-emergent adverse events (TEAEs) were monitored.
Results: Fifty-three participants were treated. From baseline to the final study visit, the mean volume increased for the jawline and decreased for the submental area. There was a larger percentage change from baseline in the minor versus major strain event, indicating greater skin surface compression than expansion within the submental area. Mean change from baseline in submental skin position indicated superior and posterior movement from a lateral perspective, while the mean submental angle decreased between baseline and exit. Collagen I and III expression significantly increased from baseline (P<0.05). All participants reported at least 1 TEAE; the majority were mild or moderate in severity.
Conclusions: Dual-modality treatment with ATX-101 and VYC-20L reduces submental fat and improves jawline definition with quantifiable changes in jawline volume, submental volume, strain, skin displacement, and angle, as well as collagen expression.

 J Drugs Dermatol. 2024;23(1):1325-1331.        doi:10.36849/JDD.7458

INTRODUCTION

An excess of submental fat (SMF) can lead to an unappealing submental profile and poor jawline definition, thus affecting the overall appearance of the face.1 As a result, individuals may seek aesthetic treatments for improving submental convexity and jawline contour.1,2 ATX-101 (deoxycholic acid injections; Kybella [US]/Belkyra [Canada, Australia, Europe, and South Korea]; Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA) is a cytolytic agent that causes lysis of adipocytes and is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with SMF.3-7 In the ATX-101 phase 3 trials, skin laxity did not worsen and even showed improvements (ie, less wrinkling/lines, adherence to underlying structures) in the majority of participants despite reductions in SMF.5,6,8 These results suggest that local inflammatory responses following ATX-101 treatment may induce neocollagenesis.8,9 

A phase 4, prospective, open-label, multicenter, interventional study showed that sequential treatment using ATX-101 followed by VYC-20L (Juvederm Voluma with Lidocaine, Allergan Aesthetics), a hyaluronic acid (HA) filler used to restore facial volume in the midface10,11 and structurally support the chin,12,13 reduced SMF, and improved jawline definition.14 Most of the participants (92.9%) achieved 1-point or greater improvement from 
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