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Reduction of unwanted submental fat with ATX ‐101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III , randomized, placebo‐controlled study
Author(s) -
Rzany B.,
Griffiths T.,
Walker P.,
Lippert S.,
McDiarmid J.,
Havlickova B.
Publication year - 2014
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.12695
Subject(s) - medicine , placebo , clinical endpoint , randomized controlled trial , adverse effect , chin , surgery , urology , gastroenterology , pathology , alternative medicine , anatomy
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.