Sue Ellen Cox

Safety and Tolerability of High-Intensity Focused Ultrasonography for Noninvasive Body Sculpting: 24-Week Data From a Randomized, Sham-Controlled Study

BACKGROUND High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. OBJECTIVES The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. METHODS Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. RESULTS Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. CONCLUSIONS This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.

Social implications of hyperdynamic facial lines and patient satisfaction outcomes.

The aesthetic use of botulinum toxin type A (BTX-A) has revolutionized strategies for treating signs of facial aging. On closer inspection, BTXA also affects nonverbal communication. The face is the focus of human communication. Facial appearance is a compilation of both the primary morphologic features and emotional expressivity. Repeated expressions produce hyperfunctional facial lines, and their presence in repose may transmit erroneous emotions or invalid personality traits. This in turn may evolve into a source of considerable anxiety, particularly during social interactions. BTX-A injections are a safe and effective means of relaxing these hyperfunctional facial muscles, thereby inhibiting hyperfunctional facial lines. BTX-A treatment may actually improve the accuracy of nonverbal communication by reducing errant messages. Results of BTX-A treatment may be objectively measured through patient reported outcome studies. The Facial Line Treatment Satisfaction (FTS) Questionnaire was developed to define and document the individual factors that determine patient satisfaction with treatment. One hundred fifty-two participants who received BTX-A alone, or in combination with anotherminimally invasive treatment, reported that they were either satisfied or very satisfied with both the effects of the treatment and the procedure itself. For physicians, the goal of any aesthetic treatment is to achieve patient happiness. Understanding the level of patient satisfaction with a particular procedure is essential when discussing the options and potential outcomes for facial line treatment. Experience suggests that BTX-A is an incomparable therapy for certain facial lines; however, no previous studies have thoroughly evaluated patient satisfaction with the results of BTX-A treatment or the procedure itself. The results of the questionnaire

The efficacy of external ultrasound-assisted liposuction : A randomized controlled trial

Background. Use of high‐intensity, high‐frequency external ultrasound before liposuction has been reported to enhance the ease of fat extraction, increase the amount of fat extracted, and decrease patient discomfort during liposuction. Objective. The purpose of this study was to compare the effect of application of high‐intensity continuous wave ultrasound to extremely low‐intensity ultrasound (placebo) prior to tumescent liposuction. Methods. A total of 19 patients (25 sites) completed the double‐blind study. We used a split treatment area design so that each patient could serve as their own control. After tumesing the treatment area, a 3 W/cm2 continuous wave 1 MHz ultrasound was applied for 10 minutes. The placebo control was treated with 0.3 W/cm2 1 MHz for 10 minutes. Traditional tumescent liposuction followed ultrasound application. Doctors completed a visual analog scale rating the following: rate of extraction, degree of resistance to cannula movement, and color of fat. Patients also completed a questionnaire after the procedure and at 1 month postoperatively. Histologic samples of the fat treated with external ultrasound were taken from two patients. Results. In 14 of 19 patients the doctors graded either no difference between treatment and control sides or found a better response on the nontreated side in rate of fat removal and resistance to cannula advancement giving a P value of .0096. Only 5 of 19 aspirates were graded as differing in redness between treatment and control sides. Four of these were more red on the control side and one was more red on the treatment side. Therefore 15 of 19 had no better result with treatment, giving a P value of .0022. Seven patients graded the sensation during suctioning and/or postoperative course as better on the control side, four graded these variables as better on the treatment side, four showed no difference between the two sides, and four had mixed results. This gives only 4 of the 19 patients showing any advantage in treatment with a P value of .0022. Conclusion. When the placebo effect is eliminated, there is no advantage to the application of external ultrasound prior to liposuction.

OnabotulinumtoxinA Dose-Ranging Study for Hyperdynamic Perioral Lines

BACKGROUND Few dosing data on onabotulinumtoxinA to treat hyperdynamic perioral lines (POLs) are available. Studying onabotulinumtoxinA in controlled settings is beneficial to treating a hyperfunctional orbicularis oris. OBJECTIVE To compare the dose‐response relationship of two doses of onabotulinumtoxinA in hyperdynamic POLs. METHODS Female subjects (N = 60) received injections of onabotulinumtoxinA at four sites totaling 7.5 U or 12.0 U. Subjects returned at weeks 2, 4, 8, 12, 16, and 20. POL severity and total lip satisfaction (TLS) were assessed at all visits. RESULTS Investigator‐assessed POL severity was reduced through week 20 for 12.0 U (p < .01). POL reduction for 7.5 U persisted until week 16 (p < .05). Responder rates did not differ until week 12 (12.0 U, 77%; 7.5 U, 36%; p = .003). Subject‐assessed TLS was improved (p < .05) at all time points for both groups except at week 20 (12.0 U; p = .06). Most adverse events (AEs) were mild to moderate in severity and typical for onabotulinumtoxinA treatment in the lips, and the incidence was dose‐dependent. CONCLUSION OnabotulinumtoxinA provides significant reductions in POL severity and high levels of subject satisfaction. Lack of dose response and fewer AEs suggest that treatment of hyperdynamic POLs with 7.5 U appears adequate for up to 16 weeks.

A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years

Background Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD). Objectives The effectiveness of Juvéderm Voluma XC was examined from the patient perspective. Methods Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries. Results At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks. Conclusions Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years. Level of Evidence 4 Therapeutic

An analysis of the long-term safety data of repeat administrations of botulinum neurotoxin type A-ABO for the treatment of glabellar lines.

BACKGROUND A new formulation of botulinum neurotoxin type A (BoNTA-ABO; Dysport [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ) was recently approved by the US Food and Drug Administration for the treatment of moderate to severe glabellar lines. OBJECTIVE To assess the long-term safety of repeat administrations of BoNTA-ABO for the treatment of glabellar lines, including variable dosing. This report summarizes an interim analysis that does not address the efficacy profile. METHODS Over 24 months, 1415 subjects underwent open-label retreatment with BoNTA-ABO. Patients were retreated with 50 units or a variable dose of 50, 60, 70, or 80 units based on gender and muscle mass. Dose was divided among five points in the glabellar region. Retreatments were performed if at least 85 days had elapsed between treatments and the glabellar line severity score was reassessed as moderate or severe. Patients were followed up at seven, 14, and 30 days postinjection, then monthly. Endpoints were adverse events (AE). RESULTS Of 1415 patients, 932 (66%) experienced at least one AE. The rate of treatment-emergent AE (TEAE) was similar in both the fixed- and variable-dose groups. Most TEAE were rated mild (70%) or moderate (20%). The majority (87%; 3361/3861) of all TEAE instances were considered not related or unlikely to be related to study treatment. The overall incidence of TEAE and related events remained relatively constant or decreased over repeat cycles. CONCLUSIONS Multiple cycles with fixed or variable dosing of BoNTA-ABO are well tolerated. There was no evidence of cumulative safety issues because the incidence of AE remained relatively constant or decreased over repeated treatment cycles.

Facial aesthetics: achieving the natural, relaxed look.

When patients undergoing nonsurgical facial rejuvenation procedures are asked to state their expectations in terms of outcomes, the achievement of a “natural, relaxed look” usually emerges as the paramount goal. The importance to clinicians of delivering on this patient desire is becoming increasingly clear. After all, patient satisfaction is the ultimate treatment goal. This article explores aspects of what defines the natural, relaxed look and what patients are seeking when they undergo nonsurgical facial rejuvenation procedures and is based on the clinical experience of the authors. The article also offers suggestions intended to help clinicians provide each patient with appropriate outcomes and satisfaction.

Patient-Reported Outcomes of Bimatoprost for Eyelash Growth

BACKGROUND Hypotrichosis of the eyelashes may negatively influence an individuals self-perception and appearance. Assessing the impact of treatment from a patients perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). OBJECTIVES The authors assess patient-reported outcomes (PRO) after treatment with bimatoprost for hypotrichosis of the eyelashes. METHODS In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). RESULTS By week 16, the bimatoprost group reported significantly greater improvements from baseline on all ESQ items (P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). CONCLUSIONS The bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults.

Delayed Migration of Hyaluronic Acid Fillers: A New Complication?

(right thigh and left chest wall) and normal wholebody MRI in the interim, a metastatic lesion is unlikely. We conducted an electronic literature search for cases of two primary DFSP lesions occurring in the same patient. We were able to find only one case report of a patient noting two separate DFSP lesions occurring in separate pregnancies. The reason for the rarity of reported second primary tumors is unknown but could be because of the mathematical probability of a second rare acquired disease occurring in the same patient. Furthermore, this case demonstrates features of the Bednar and fibrosarcomatous subtypes, which is an uncommon occurrence that has not been reported in a second primary DFSP.

OnabotulinumtoxinA for Treatment of Moderate to Severe Crow's Feet Lines: A Review

Lateral canthal lines or crows feet lines (CFL) may be treated with onabotulinumtoxinA. We identified several key concepts important to understanding the use of onabotulinumtoxinA for treatment of moderate-to-severe CFL. To contextualize and integrate data on the recommended dose and injection patterns of onabotulinumtoxinA for treatment of CFL, we summarized data from pivotal clinical studies in the development of onabotulinumtoxinA for treatment of CFL. Data from key studies of onabotulinumtoxinA for CFL are presented. The efficacy and safety of onabotulinumtoxinA treatment of moderate-to-severe CFL were evaluated in 2 randomized, controlled phase 3 studies comprising 1362 patients. The 24U total dose of onabotulinumtoxinA used in these studies was based on a phase 2 dose-ranging trial. Two injection patterns were available to investigators; each involved 3 injection sites per side in the lateral orbicularis oculi muscle. A cross-sectional analysis of photographs from the phase 3 trials provided detailed information on the frequency of 4 distinct CFL patterns. In the primary efficacy analysis for each phase 3 trial, CFL responder rates were significantly greater with onabotulinumtoxinA vs placebo at day 30 (P< .001). Eyelid edema (1%) was the only adverse event reported in ≥ 1% of patients receiving onabotulinumtoxinA, occurring more frequently with onabotulinumtoxinA than with placebo. The studies showed that onabotulinumtoxinA is effective and generally well-tolerated for CFL treatment. Additionally, 2 different injection patterns allow physicians to tailor treatment based on a patients CFL pattern.