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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]

Objective: To evaluate the safety and pharmacokinetics of tazarotene cream 0.1% under standard (face only) or exaggerated (15% body surface area, including the face) application conditions after a single dose and after repeat topical applications once daily to patients with acne vulgaris or photodamaged skin. Methods: Two separate, randomised, single-centre, nonblinded, parallel-group pharmacokinetic studies were conducted. In one study, tazarotene cream 0.1% was applied either to the face of eight female patients with moderate acne or to 15% body surface area of ten female patients with severe acne. In the other study, tazarotene cream 0.1% was applied either to the face (six females, two males) or to 15% body surface area (8 females. 8 males) of patients with photodamaged skin. In both studies, tazarotene cream 0.1% was applied once daily (except on days 1 and 2) for 30 days. Blood was drawn for measurement of plasma concentrations of tazarotenic acid at defined time intervals after applicat ion of the cream. Plasma tazarotenic acid concentrations were determined by a validated gas chromatography-tandem mass spectrometry method with a lower limit of quantification of 0.005 μg/L. Results: At exaggerated application rates in patients with acne vulgaris, the maximum average peak concentration (C[submax]) and 24-hour area under the concentration-time curve (AUC) values of tazarotenic acid were (mean ± SD) 1.20 ± 0.41 μg/L (n = 10) and 17.0 ±6.1 μg · h/L (n = 10), respectively, and occurred on day 15. The single highest C[submax] was 1.91 μg/L. At standard application rates in patients with acne vulgaris, the maximum average C[submax] and AUC values of tazarotenic acid were 0.10 ± 0.06 μg/L (n = 8) and 1.54 ± 1.01 μg · h/L (n = 8), respectively, and occurred on day 15. At exaggerated application rates in patients with photodamaged skin, the maximum average C[submax] and AUC values of tazarotenic acid were (mean ± SD) 1.75 ± 0.53 μg/L (n = 16) and 23.8 ± 7.0 μg • h/L (n = 16), respectively, and occurred on day 22. The single highest C[submax] was 3.43 μg/L on day 29. At standard application rates in patients with photodamaged skin, the maximum average C[submax] and AUC values of tazarotenic acid were 0.236 ± 0.255 μg/L (n = 8) and 2.44 ± 1.38 μg · h/L (n = 8), respectively, and occurred on day 15. Gender had no influence on the systemic exposure of tazarotenic acid. The most common treatment-related adverse events were signs and symptoms of local irritation, of mild or moderate severity. Conclusions: The pharmacokinetics of tazarotene cream 0.1% in patients with acne vulgaris or photodamaged skin are similar. The maximum average plasma concentrations of tazarotenic acid after topical application of tazarotene cream 0.1% to the face were less than 0.25 μg/L. The maximum average plasma concentrations of tazarotenic acid following application to an exaggerated body surface area (15%) were less than 1.8 μg/L. [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]