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BACKGROUND ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm2) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction. [ABSTRACT FROM AUTHOR]

BACKGROUND A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency—which should promote long-lasting corrections and a smooth, natural look and feel postinjection. OBJECTIVE The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. METHODS AND MATERIALS A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for ≤24 weeks. RESULTS All three HA dermal fillers achieved considerably longer-lasting clinical correction than bovine collagen; 81% to 90% of HA dermal filler–treated NLFs maintained a clinically significant improvement from baseline for ≥6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. CONCLUSION The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen—which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects—which should promote patient satisfaction. [ABSTRACT FROM AUTHOR]