ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study

September 2019 | Volume 18 | Issue 9 | Original Article | 870 | Copyright © September 2019

Kenneth Beer MD,ª Susan H. Weinkle MD,B Sue Ellen Cox MD,c Mark G. Rubin MD,d Ava Shamban MD,e and Christine Somogyif

Beer Surgical, Aesthetic and General Dermatology, West Palm Beach, FL

bUniversity of South Florida, Tampa and Private Practice, Bradenton, FL

cDepartment of Dermatology, University of North Carolina School of Medicine and Aesthetic Solutions, Chapel Hill, NC

DLasky Skin Center, Beverly Hills, CA

ePrivate Practice, Santa Monica, CA

fAllergan plc, Irvine, CA

Abstract

Background: ATX-101 (deoxycholic acid) causes adipocytolysis when injected into subcutaneous fat.

Objective: Evaluate the long-term safety and efficacy of ATX-101 for submental fat (SMF) reduction.

Methods: Adults (N=165) with moderate-to-extreme SMF received ≤6 treatments of open-label ATX-101 (2 mg/cm2) and were evaluated up to 12 months after last treatment. Efficacy end points included improvements in SMF based on clinician or subject assessment, patient-reported outcomes, downtime (via subject questionnaire), and skin laxity. Safety was evaluated throughout the study.

Results: Twelve weeks after last treatment, most subjects achieved a ≥1-grade improvement in SMF based on clinician (86.8%) or subject (83.8%) evaluation; at 12 months, 90.4% and 80.7% of these responders, respectively, maintained the response. Overall, 84.9% of subjects were satisfied with the appearance of their face/chin. At 12 months, 82.9% of subjects had unchanged, and 10.1% had improved, skin laxity relative to 12 weeks after last treatment. Adverse events were mild to moderate and mainly involved the treatment area. During the 7 days after the first treatment, 13.3% of subjects missed work and 33.9% missed social/leisure activities. Following subsequent treatments, 2.4%–6.0% of subjects missed work and 10.0%–15.7% missed social/leisure activities.

Conclusion: The safety and efficacy of ATX-101 were sustained over 12 months.

ClinicalTrials.gov identifier, NCT01426373

J Drugs Dermatol. 2019;18(9):870-877. 

INTRODUCTION

The submental area impacts facial harmony, balance, and attractiveness.1-3 In addition, an undesirable submental profile can negatively affect self-perception.4,5 Accumulation of submental fat (SMF) can occur in individuals not otherwise overweight and is typically resistant to weight reduction measures.6-8

Treatment options to improve submental contour have traditionally included surgical procedures.9 Nonsurgical methods of submental contouring are available, although many tighten skin rather than reduce SMF.10-13 ATX-101 (deoxycholic acid injection) is an injectable drug approved in the United States (Kybella)14 and Australia, Canada, Europe, and South Korea (Belkyra)15 for improvement in the appearance of moderate-to-severe convexity or fullness associated with SMF.

The active ingredient of ATX-101, deoxycholic acid, preferentially targets adipocytes, as the cytolytic activity is diminished in protein-rich tissues such as muscle and skin.16 When injected
into fat, ATX-101 causes adipocytolysis and a local tissue response involving macrophage infiltration to eliminate cellular debris and liberated lipids from the injection site, as well as fibroblast recruitment thought to be responsible for neocollagenesis.17-19

The safety and efficacy of ATX-101 have been assessed in 4 large randomized, controlled phase 3 trials.14,15,20-23 The current trial evaluated the safety and durability of the ATX-101 treatment effect over 12 months. The impact of ATX-101 treatment on work and social/leisure activities was also assessed.

METHODS

Study Design
This open-label, phase 3b trial (ClinicalTrials.gov identifier, NCT01426373) was conducted between August 2011 and June 2013 at 18 sites in the United States in compliance with the International Conference on Harmonization Guideline for Good Clinical Practice and the Declaration of Helsinki. All participants provided written informed consent.