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Summary   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.    Objectives  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  C linician‐ R eported  S ubmental  F at  R ating  S cale ( CR ‐ SMFRS )] and patients satisfied with their face and chin appearance on the  S ubject  S elf‐ R ating  S cale ( 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.

british journal of dermatology

Reduction of unwanted submental fat with  ATX ‐101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase  III , randomized, placebo‐controlled study