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Br J Dermatol. 2014 Feb;170(2):445-53. doi: 10.1111/bjd.12695.

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

Author information

1
Division of Evidence-Based Medicine in Dermatology, Charité-Universitätsmedizin, and RZANY & HUND, Privatpraxis und klinisches Studienzentrum für Dermatologie, Berlin, Germany.

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.

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 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.

Comment in

PMID:
24147933
PMCID:
PMC4232897
DOI:
10.1111/bjd.12695
[Indexed for MEDLINE]
Free PMC Article

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