Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

January 2019 | Volume 18 | Issue 1 | Original Article | 40 | Copyright © January 2019

Melanie D. Palm MD MBA,a Joel Schlessinger MD,b Valerie D. Callender MD,c Steven Fagien MD,d Kenneth Beer MD,e Suzanne Magante MS,f Sara Sangha PhDg

aPrivate Practice (Art of Skin MD), Solana Beach, CA bPrivate Practice (Skin Specialists PC), Omaha, NE cPrivate Practice (Callender Dermatology and Cosmetic Center), Glenn Dale, MD dPrivate Practice, Boca Raton, FL ePrivate Practice (Beer Surgical, Aesthetic and General Dermatology), West Palm Beach, FL fAllergan plc, Irvine, CA at the time the study was conducted; now at Alder Biopharmaceuticals gAllergan plc, Irvine, CA

Abstract
Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient’s decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

INTRODUCTION

Submental fullness, often caused by excess submental fat (SMF), can negatively impact facial appearance and self- perceptions of attractiveness. Surgical procedures have been the standard treatment to reduce SMF, but these options may not be suitable or desirable for all patients.2,3 In recent years, several nonsurgical treatments for submental contour- ing have been cleared (CoolSculpting, ZELTIQ Aesthetics, Inc., Pleasanton, CA, an affiliate of Allergan4 and SculpSure, Cyno- sure, Inc., Westford, MA5) or approved (ATX-101 [deoxycholic acid injection], Kybella [United States]/Belkyra [Canada, Aus- tralia, Europe, South Korea]; Kythera Biopharmaceuticals, Inc., Parsippany, NJ, an affiliate of Allergan).6,7 As additional nonsurgical treatment options with different mechanisms of action for submental contouring become available, it is important for physicians to better understand patient perspectives on submental fullness and which factors should be considered when deter- mining the most appropriate treatment for an individual patient. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was conducted to evaluate the condi- tion of submental fullness and the treatment of SMF in clinical practice. The objectives of CONTOUR were to understand the types of patients seeking SMF reduction, patient and physician treatment goals, how treatment decisions are made, and post- treatment patient and physician perspectives. Final data from CONTOUR are presented here.

METHODS

CONTOUR was a prospective observational study conducted between June 2015 and December 2016 at sites in the United