title: Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study.
abstract: BACKGROUND
  Unwanted submental fat (SMF) is aesthetically unappealing, but methods of reduction are either invasive or lack evidence for their use. An injectable approach with ATX-101 (deoxycholic acid) is under investigation.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of ATX-101 for the reduction of unwanted SMF.
  
  
  METHODS
  In this double-blind, placebo-controlled, phase III study, 363 patients with moderate/severe SMF were randomized to receive ATX-101 (1 or 2 mg cm(-2) ) or placebo injections into their SMF at up to four treatment sessions ~28 days apart, with a 12-week follow-up. The co-primary efficacy endpoints were the proportions of treatment responders [patients with ≥ 1-point improvement in SMF on the 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)] and patients satisfied with their face and chin appearance on the Subject Self-Rating Scale (SSRS). Secondary endpoints included skin laxity, calliper measurements and patient-reported outcomes. Adverse events were monitored.
  
  
  RESULTS
  Significantly more ATX-101 recipients met the primary endpoint criteria vs. placebo: on the clinician scale, 59·2% and 65·3% of patients treated with ATX-101 1 and 2 mg cm(-2) , respectively, were treatment responders vs. 23·0% for placebo (CR-SMFRS; P < 0·001); on the patient scale, 53·3% and 66·1%, respectively, vs. 28·7%, were satisfied with their face/chin appearance (SSRS; P < 0·001). Calliper measurements showed a significant reduction in SMF (P < 0·001), skin laxity was not worsened and patients reported improvements in the severity and psychological impact of SMF with ATX-101 vs. placebo. Most adverse events were transient and associated with the treatment area.
  
  
  CONCLUSIONS
  ATX-101 was effective and well tolerated for nonsurgical SMF reduction.
authors.affiliation: Division of Evidence-Based Medicine in Dermatology, Charité-Universitätsmedizin, and RZANY & HUND, Privatpraxis und klinisches Studienzentrum für Dermatologie, Berlin, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Rzany
authors.forename: T
authors.initials: T
authors.lastname: Griffiths
authors.forename: P
authors.initials: P
authors.lastname: Walker
authors.forename: S
authors.initials: S
authors.lastname: Lippert
authors.forename: J
authors.initials: J
authors.lastname: McDiarmid
authors.forename: B
authors.initials: B
authors.lastname: Havlickova
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D003840:Deoxycholic Acid / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D050151:Subcutaneous Fat / Q000187:drug effects*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D003840:Deoxycholic Acid