Efficacy, patient‐reported outcomes and safety profile of ATX‐101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo‐controlled study

Abstract

BackgroundUnwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking.ObjectiveTo evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study.MethodsPatients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm2 or placebo injected into their SMF for up to four treatments ∼28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored.ResultsCompared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm2 showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm2, P < 0.001 for ATX-101 2 mg/cm2 vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area.ConclusionATX-101 was effective and well tolerated, and may be an alternative to surgery for patients desiring improvement of their submental profile.

Deoxycholic Acid (ATX-101) for Reduction of Submental Fat

“…10 The patient population was also similar, with the majority of patients being white and female (Table 1). (2) is defined as prominent, localized SMF, and severe (3) is defined as marked, localized SMF.…”

ATX-101 for reduction of submental fat

“…Patients satisfaction with the treatment received was scored by subject global questions ('a great deal worse' to 'a great deal better', 'extremely dissatisfied' to 'extremely satisfied'). In this study protocol, SLRS was classified as 'other efficacy outcome' not 'secondary efficacy outcome' [38].…”

“…Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the safety and efficacy of ATX-101 (NCT00618618) . Interventional nonrandomized long-term, follow-up study of patients who completed Phase III trials of ATX-101-10-16 or ATX-101-10-17 (NCT02052622) [31][32][33][34][35][36][37][38][39].…”

Addressing the “Double Chin:” Trends in Submental Contouring

“…The mechanism of action of this injection is through its bile acid properties of emulsifying and solubilising fat. The product promotes adipocyte lysis through disruption of the cell membrane [16,17]. The REFINE-1 and REFINE-2 studies demonstrated that ATX-101 significantly reduced submental fat in comparison to placebo.…”

“…Furthermore, patients reported a high level of selfperceived improvement after the treatment [18]. The product was generally well-tolerated with few patients reporting adverse events [16,18].…”