A Prospective, Multicenter, Evaluator-Blind, Randomized, Controlled Study of Belotero Balance (+), a Hyaluronic Acid Filler With Lidocaine, for Correction of Infraorbital Hollowing in Adults.

BACKGROUND: The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be utilized to correct volume deficit in the under-eye area, restoring a more youthful appearance. OBJECTIVES: The objective was to demonstrate the effectiveness and safety of a cohesive polydensified matrix (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance (+)) for correcting volume deficit in the IOH. METHODS: Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated with the MIHAS. Adverse events were recorded over a 76-week period. RESULTS: The estimated average response rate (≥1 point MIHAS improvement) was 80.6% (95% CI, 71.4-87.4) in treated patients and 1.9% (95% CI, 0.3-10.2) in controls at Week 8. The difference in estimated response rates was 78.7% (95% CI, 66.3-85.6), demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88 of 97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. CONCLUSIONS: Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.

Real-world effectiveness and safety of collagenase clostridium histolyticum-aaes injections for the treatment of thigh cellulite in women: An open-label study interim analysis.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women. AIM: Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite. METHODS: Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas. RESULTS: Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively). CONCLUSIONS: CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.

Perception of Beauty in the Visually Blind: A Pilot Observational Study.

BACKGROUND: Blind individuals have demonstrated the ability to detect danger and facial expressions without conscious awareness of visual stimuli. These embodied sensations are believed to be the result of primitive neural networks refined by evolutionary adaptations. We postulate that similar embodied sensations may have evolved to allow blind individuals to perceive beauty. OBJECTIVE: To determine whether the visually blind can detect physical beauty. PATIENTS AND METHODS: This observational study consisted of 8 blind and 10 nonblind test subjects and 6 models that were categorized into predetermined beauty categories. Test subjects were individually asked to rate 6 models on a 1 to 10 numerical beauty scale. This process was repeated in both groups while blindfolded (masked). All groups' mean model beauty scores underwent multivariate and univariate analysis. RESULTS: All groups rated preselected (greater than 8) more beautiful models, higher except for the masked, nonblind group. Intraclass correlation was good in the blind raters with a score of 0.751, whereas poor in the nonblind masked raters with a score of 0.458. CONCLUSION: This is the first pilot study demonstrating with supporting evidence that blind individuals can detect beauty and supports that beauty may rely on primal forms of messaging that are subconsciously appreciated.

Patient Satisfaction and Patients' Family or Significant Other Perceptions After OnabotulinumtoxinA Treatment: A Prospective Cross-Sectional Study.

BACKGROUND: OnabotulinumtoxinA treatment is associated with improved emotional well-being in patients. OBJECTIVE: This study aimed to determine satisfaction with onabotulinumtoxinA treatment in patients naive to neurotoxin treatment and patients with previous experience with the procedure and evaluate treatment impact on patients' partners, "significant others," or close family members. MATERIALS AND METHODS: Patients' satisfaction and their family's/significant other's perception to treatment outcome were assessed in a prospective, cross-sectional study using standardized questionnaires. RESULTS: OnabotulinumtoxinA treatment was associated with high patient satisfaction ranging from 80% to 100%. Study patients (61 patients) reported that their faces appeared to be more balanced and symmetrical (mean difference, 1.05) and that they looked much better in photographs (mean difference, 1.43), with their significant others also noting the improvement in appearance. Overall, 98% of patients expressed that they would undergo retreatment, and 100% expressed that they would recommend the procedure to others. The main obstacle for treatment repetition was economic constraints (26%). CONCLUSION: OnabotulinumtoxinA treatment is one of the most precise and predictable cosmetic treatments available, with high patient satisfaction (97%). A positive outcome of onabotulinumtoxinA treatment, as expressed by patients surveyed using standardized questionnaires, was the appreciation and acceptance by those in close contact with them.

Differential Synaptic Remodeling by Dopamine in Direct and Indirect Striatal Projection Neurons in Pitx3-/- Mice, a Genetic Model of Parkinson's Disease.

In toxin-based models of Parkinson's disease (PD), striatal projection neurons (SPNs) exhibit dendritic atrophy and spine loss concurrent with an increase in excitability. Chronic l-DOPA treatment that induces dyskinesia selectively restores spine density and excitability in indirect pathway SPNs (iSPNs), whereas spine loss and hyperexcitability persist in direct pathway SPNs (dSPNs). These alterations have only been characterized in toxin-based models of PD, raising the possibility that they are an artifact of exposure to the toxin, which may engage compensatory mechanisms independent of the PD-like pathology or due to the loss of dopaminergic afferents. To test all these, we studied the synaptic remodeling in Pitx3-/- or aphakia mice, a genetic model of PD, in which most of the dopamine neurons in the substantia nigra fail to fully differentiate and to innervate the striatum. We made 3D reconstructions of the dendritic arbor and measured excitability in identified SPNs located in dorsal striatum of BAC-Pitx3-/- mice treated with saline or l-DOPA. Both dSPNs and iSPNs from BAC-Pitx3-/- mice had shorter dendritic trees, lower spine density, and more action potentials than their counterparts from WT mice. Chronic l-DOPA treatment restored spine density and firing rate in iSPNs. By contrast, in dSPNs, spine loss and hyperexcitability persisted following l-DOPA treatment, which is similar to what happens in 6-OHDA WT mice. This indicates that dopamine-mediated synaptic remodeling and plasticity is independent of dopamine innervation during SPN development and that Pitx3-/- mice are a good model because they develop the same pathology described in the toxins-based models and in human postmortem studies of advanced PD.SIGNIFICANCE STATEMENT As the only genetic model of Parkinson's disease (PD) that develops dyskinesia, Pitx3-/- mice reproduce the behavioral effects seen in humans and are a good system for studying dopamine-induced synaptic remodeling. The studies we present here establish that the structural and functional synaptic plasticity that occur in striatal projection neurons in PD and in l-DOPA-induced dyskinesia are specifically due to modulation of the neurotransmitter dopamine and are not artifacts of the use of chemical toxins in PD models. In addition, our findings provide evidence that synaptic plasticity in the Pitx3-/- mouse is similar to that seen in toxin models despite its lack of dopaminergic innervation of the striatum during development. Pitx3-/- mice reproduced the alterations described in patients with advanced PD and in well accepted toxin-based models of PD and dyskinesia. These results further consolidate the fidelity of the Pitx3-/- mouse as a PD model in which to study the morphological and physiological remodeling of striatal projection neurons by administration of l-DOPA and other drugs.

Relationship of abdominal adiposity and body composition with endothelial dysfunction in patients with rheumatoid arthritis.

OBJECTIVES: We aimed to investigate whether the abnormalities in body composition and abdominal fat that occur in rheumatoid arthritis (RA) are associated with the presence of endothelial dysfunction. METHODS: Cross-sectional study that encompassed 197 women (100 RA patients and 97 age-matched controls). Patients and controls were evaluated to establish endothelial function by brachial artery flow-mediated dilatation (FMD). Dual-x-ray-absorptiometry-derived body composition and abdominal adiposity by magnetic resonance imaging were assessed. Multiple regression analysis was performed to study the relationship between body composition and endothelial function. RESULTS: FMD was higher in controls compared to RA patients (8.5 [4.5-15.6] % vs. 5.3 [0.0-9.2] %, p=0.00). Appendicular-to-total lean mass ratio (0.42 ± 0.02 vs. 0.40 ± 0.03, p=0.00) and appendicular-to-trunk lean mass (0.82 ± 0.08 vs. 0.78 ± 0.08, p=0.00) were lower in RA patients. Visceral and subcutaneous abdominal fat tissues did not differ between patients and controls. Body mass index over 30 kg/m2 was common in patients and controls (44 and 32%). High sarcopenia tended to be more elevated in RA after multivariate adjustment (13% vs. 7%, p=0.06). Fat mass index showed a negative association (per standard deviation-SD-), after adjusting for comorbidity, with FMD in controls (beta coef. -0.45[-1.05-0.05], p=0.03) but not in patients. Overfat definition (beta coef. -0.81[-1.73-0.00], p=0.05) and visceral fat (per SD beta coef. -0.60 [-1.18-0.02], p=0.04) were associated with a lower FMD values in controls but not in RA patients. Trend analysis revealed that sarcopenia was related to increased endothelial dysfunction in both patients and controls. CONCLUSIONS: Our findings suggest that fat accumulation is not associated with endothelial dysfunction in RA patients. However, RA patients with sarcopenia are more likely to suffer endothelial dysfunction possibly being at higher cardiovascular risk.

Volumetric considerations for lower eyelid and midface rejuvenation.

PURPOSE OF REVIEW: With the accepted understanding of volume loss as one of the main factors in facial aging, oculofacial surgeons are embracing the concept of 'removing' less and 'filling' more. The purpose of this review is to present an update of the different alternatives and techniques for lower eyelid and midface restoration/rejuvenation using filler agents. RECENT FINDINGS: When a filler agent is chosen, the aim is to provide some lift, support and sculpting to the treated area. Nonpermanent or semi-permanent fillers are most widely accepted by physicians mainly because there is a lower possibility of complications. The involutional changes in the facial structures are a continuous process; this requires reassessment and variation in techniques in addition to choosing different products at different ages. Safety, support capability, ease of injection and cost are the factors to consider when choosing an injectable implant. But, physicochemical structure or rheological properties, such as viscosity and elasticity, enable the clinician to objectively select the most appropriate injectable implant depending on the specific anatomical area. An injectable with low viscosity may be ideal for lip enhancement wherein softness is required, whereas a higher viscosity filler or a harder filler may be better indicated for structure and support in the midface. SUMMARY: Given the wide variety of filler materials available, clinicians and surgeons must be able to select products based on safety, lifting or sculpting capability and rheological properties, such as viscosity and elasticity. These factors provide an objective parameter of how the filler agent will perform in a specific area.