Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.

BACKGROUND: There is a growing trend toward the use of blunt-tip microcannulas for the treatment of midface volume loss with injectable hyaluronic acid. OBJECTIVE: To evaluate the safety and efficacy of large gel particle hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, for cheek augmentation and the correction of age-related midface contour deficiency. MATERIALS AND METHODS: Sixty subjects with mild to substantial loss of midface fullness were treated to optimal correction. Adverse events (AEs) were obtained during each examination visit. Efficacy was evaluated using the Global Aesthetic Improvement Scale, the Medicis Midface Volume Scale (MMVS), and the FACE-Q subject satisfaction questionnaire through 16 weeks. RESULTS: Five AEs were reported, with only one being considered injection procedure-related (mild presyncope). No serious AEs were reported. Global aesthetic improvements were reported for the majority of subjects (≥98.3% for investigator-assessed and ≥91.5% for subject-assessed) for up to 16 weeks. At 8 weeks, the MMVS responder rate was 100% and subject satisfaction scores (5/6 questions) in the FACE-Q were ≥91.5%. CONCLUSION: Hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, has a favorable safety profile and is effective up to 16 weeks for cheek augmentation and the correction of age-related midface contour deficiencies (NCT03160716).

Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the Treatment of Glabellar Lines.

BACKGROUND: Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction. OBJECTIVE: Comparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes. MATERIALS AND METHODS: Phase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed. RESULTS: At Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported. CONCLUSION: Both ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.

Minimal recovery time needed to return to social engagement following nasolabial fold correction with hyaluronic acid fillers produced with XpresHAn technology.

INTRODUCTION: The appeal of hyaluronic acid fillers for facial soft tissue augmentation is attributable to both an immediate aesthetic effect and relatively short recovery time. Although recovery time is an important posttreatment variable, as it impacts comfort with appearance and perceived treatment benefit, it is not routinely evaluated. Natural-looking aesthetic outcomes are also a primary concern for many patients. MATERIALS AND METHODS: A single-center, noncomparative study evaluated the time (in hours) until subjects return to social engagement (RtSE) following correction of moderate and severe nasolabial folds (NLFs) with RR (Restylane® Refyne)® and RD (Restylane Defyne), respectively. Twenty subjects (aged 35-57 years) who received bilateral NLF correction documented their RtSE and injection-related events posttreatment. Treatment efficacy was evaluated by improvements in Wrinkle Severity Rating Scale (WSRS) and subject satisfaction questionnaire at days 14 and 30, and by Global Aesthetic Improvement Scale (GAIS) at day 30. Safety was evaluated by injection-related events and treatment-emergent adverse events. RESULTS: Fifty percent of subjects reported RtSE within 2 hours posttreatment. WSRS for the RR group improved significantly from baseline at day 14 (-1.45±0.42) and day 30 (-1.68±0.46) (P<0.001), respectively. WSRS for the RD group improved significantly from baseline at day 14 (-2.22±0.44) and day 30 (-2.50±0.50) (P<0.004), respectively. All GAIS improvements were clinically significant at day 30. The majority of injection-related events were mild or moderate. Two subjects experienced 3 related treatment-emergent adverse events; 1 RR subject experienced severe bruising, and 1 RD subject experienced severe erythema and mild telangiectasia. Subject satisfaction was high regarding aesthetic outcomes and natural-looking results. CONCLUSION: Optimal correction of moderate NLFs with RR and severe NLFs with RD involved minimal time to RtSE for most subjects. Treatments that significantly improved WSRS and GAIS, were generally well-tolerated, and provided natural-looking aesthetic outcomes.

Discovery and characterization of novel tryptophan hydroxylase inhibitors that selectively inhibit serotonin synthesis in the gastrointestinal tract.

5-Hydroxytryptamine (serotonin) (5-HT) is a neurotransmitter with both central and peripheral functions, including the modulation of mood, appetite, hemodynamics, gastrointestinal (GI) sensation, secretion, and motility. Its synthesis is initiated by the enzyme tryptophan hydroxylase (TPH). Two isoforms of TPH have been discovered: TPH1, primarily expressed in the enterochromaffin cells of the gastrointestinal tract, and TPH2, expressed exclusively in neuronal cells. Mice lacking Tph1 contain little to no 5-HT in the blood and GI tract while maintaining normal levels in the brain. Because GI 5-HT is known to play important roles in normal and pathophysiology, we set out to discover and characterize novel compounds that selectively inhibit biosynthesis of GI 5-HT. Here, we describe two of a series of these inhibitors that are potent for TPH activity both in biochemical and cell-based assays. This class of compounds has unique properties with respect to pharmacokinetic and pharmacodynamic effects on GI serotonin production. Similar to the Tph1 knockout results, these TPH inhibitors have the ability to selectively reduce 5-HT levels in the murine GI tract without affecting brain 5-HT levels. In addition, administration of these compounds in a ferret model of chemotherapy-induced emesis caused modest reductions of intestinal serotonin levels and a decreased emetic response. These findings suggest that GI-specific TPH inhibitors may provide novel treatments for various gastrointestinal disorders associated with dysregulation of the GI serotonergic system, such as chemotherapy-induced emesis and irritable bowel syndrome.