title: ATX-101 for reduction of submental fat: A phase III randomized controlled trial.
abstract: BACKGROUND
  ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.
  
  
  OBJECTIVE
  We sought to evaluate the efficacy and safety of ATX-101.
  
  
  METHODS
  In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes.
  
  
  RESULTS
  Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site.
  
  
  CONCLUSIONS
  Follow-up was limited to 44 weeks.
  
  
  CONCLUSIONS
  ATX-101 is an alternative treatment for SMF reduction.
authors.affiliation: University of British Columbia, Vancouver, British Columbia, Canada; Carruthers & Humphrey, Vancouver, British Columbia, Canada. Electronic address: shannon@carruthers-humphrey.com.
authors.forename: Shannon
authors.initials: S
authors.lastname: Humphrey
authors.affiliation: University of California, Davis, Sacramento, California.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Sykes
authors.affiliation: Florida Center for Dermatology PA, St. Augustine, Florida; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kantor
authors.affiliation: University of Toronto and Women's College Hospital, Toronto, Ontario, Canada; Bertucci MedSpa, Woodbridge, Ontario, Canada.
authors.forename: Vince
authors.initials: V
authors.lastname: Bertucci
authors.affiliation: Kythera Biopharmaceuticals, Inc, Westlake Village, California.
authors.forename: Patricia
authors.initials: P
authors.lastname: Walker
authors.affiliation: Kythera Biopharmaceuticals, Inc, Westlake Village, California.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Lee
authors.affiliation: Kythera Biopharmaceuticals, Inc, Westlake Village, California.
authors.forename: Paul F
authors.initials: PF
authors.lastname: Lizzul
authors.affiliation: Kythera Biopharmaceuticals, Inc, Westlake Village, California.
authors.forename: Todd M
authors.initials: TM
authors.lastname: Gross
authors.affiliation: Kythera Biopharmaceuticals, Inc, Westlake Village, California; David Geffen School of Medicine, University of California, Los Angeles, California.
authors.forename: Frederick C
authors.initials: FC
authors.lastname: Beddingfield
mesh_terms: D017667:Adipocytes / Q000187:drug effects / Q000378:metabolism; D000328:Adult; D000368:Aged; D002170:Canada; D003357:Cosmetic Techniques; D003840:Deoxycholic Acid / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004954:Esthetics; D006801:Humans; D007279:Injections, Subcutaneous; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008875:Middle Aged; D061214:Patient Safety; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D050151:Subcutaneous Fat / Q000000981:diagnostic imaging* / Q000187:drug effects*; D014481:United States
chemical_list: D003840:Deoxycholic Acid
keywords: ATX-101; aesthetics; contouring; deoxycholic acid; efficacy; injectable; minimally invasive; nonsurgical; safety; submental fat