ATX-101 for reduction of submental fat: A phase III randomized controlled trial

BackgroundATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.ObjectiveWe sought to evaluate the efficacy and safety of ATX-101.MethodsIn this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging–based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes.ResultsAmong those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site.LimitationsFollow-up was limited to 44 weeks.ConclusionATX-101 is an alternative treatment for SMF reduction

Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers

Many patients elect to have repeat treatments with hyaluronic acid dermal fillers to maintain wrinkle correction, but the clinical performance of these products after repeat treatments has not been formally assessed. The primary objective of this study was to evaluate the effectiveness of Juvéderm injectable gel (Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm 30) through 1 year after repeat treatment of nasolabial folds (NLFs) that were previously treated with Juvéderm or Zyplast 6–9 months prior to the repeat treatment. Upon completion of the pivotal IDE clinical trial for Juvéderm, five of the original 11 study sites were selected to participate in an extended follow-up evaluation, and a total of 80 subjects were enrolled. For the Juvéderm-treated NLFs in each treatment group, the median injection volume was 1.5–1.6 mL for initial treatment but only 0.5–0.6 mL for the repeat treatment (p < 0.0001). Mean Investigator-assigned NLF severity scores on a scale of 0–4 for the Juvéderm-treated NLFs improved from 2.5–2.7 (moderate to severe) at baseline to 1.2–1.5 (mild) just prior to repeat treatment (>24 weeks) and 0.7–0.9 (mild) at 4 weeks after repeat treatment. At 48 weeks post-repeat treatment, the mean NLF scores were 1.1–1.3 (mild), and 78–90% of subjects were considered responders (≥1 point improvement). Thus, subjects sustained a total of 18–21 months of wrinkle correction with a repeat treatment at 6–9 months and needed substantially less filler (60% less) for repeat treatment than for initial treatment, indicating that retreatment at this timepoint may be beneficial to patients