Higher Responder Rates Observed With Live Participant Assessment Versus Photographic Assessment After VYC-20L Hyaluronic Acid Treatment for Chin Augmentation.

BACKGROUND: In an evaluator-blinded, randomized controlled trial, the hyaluronic acid soft-tissue filler VYC-20L injectable gel was safe and effective for correcting volume deficits and retrusion in the chin. OBJECTIVES: The objective of this subanalysis was to compare responder rates obtained with photographic vs live assessments. METHODS: Participants were randomized 3:1 to VYC-20L treatment or a 6-month, no-treatment control period followed by optional treatment. Responder rates (≥1-point improvement from baseline on the validated Allergan Chin Retrusion Scale [ACRS]) obtained with photographic assessments and live assessments at Month 6 were compared. Prespecified subgroup analyses compared responder rates by baseline ACRS severity, filler volume, cannula usage, and investigation site. RESULTS: VYC-20L was effective for chin augmentation as evaluated with both live and photographic assessments. The ACRS responder rates at Month 6 were 91.8% with live assessments and 56.3% with photographic assessments. Consistently higher response rates were observed by live vs photographic assessment regardless of baseline ACRS severity, filler volume, cannula usage, and investigation site. CONCLUSIONS: Live assessment of ACRS response after VYC-20L treatment resulted in higher responder rates than photographic assessment, supporting the use of live assessment for this indication to approximate real-world clinical practice.

High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). OBJECTIVE: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. MATERIALS AND METHODS: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. RESULTS: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. CONCLUSION: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.

Facial Aesthetic Priorities and Concerns: A Physician and Patient Perception Global Survey.

BACKGROUND: Minimally invasive and noninvasive facial aesthetic treatments are increasingly popular, and a greater understanding of patient perspectives on facial aesthetic priorities is needed. OBJECTIVES: The authors surveyed facial aesthetic concerns, desires, and treatment goals of aesthetically conscious men and women, and physicians, in 18 countries. METHODS: This was a global, internet-based survey on desired appearance and experiences with, or interest in, facial aesthetic treatments. Eligible respondents were aesthetically conscious adults (21-75 years). Eligible aesthetic physicians were required to see ≥30 patients per month for aesthetic reasons, have 2 to 30 years of experience in clinical practice, and spend ≥70% of their time in direct patient care. RESULTS: A total of 14,584 aesthetically conscious adults (mean age, 41 years; 70% women) and 1315 aesthetic physicians (mean age, 45 years; 68% men) completed the survey. Most respondents (68%) reported that aesthetic procedures should be sought in their 30s to 40s; physicians recommended patients seek treatment earlier. Respondents expressed greatest concern over crow's feet lines, forehead lines, facial skin issues, hair-related concerns, and under-eye bags or dark circles; in contrast, physicians tended to underestimate concerns about under-eye bags or dark circles, mid-face volume deficits, and skin quality. Although both physicians and respondents cited cost as a major barrier to seeking aesthetic treatments, respondents also emphasized safety, fear of injections or procedure-related pain, and concern about unnatural-looking outcomes. CONCLUSIONS: This global survey provides valuable insight into facial aesthetic concerns and perspectives that may be implemented in patient education and consultations to improve patient satisfaction following aesthetic treatments.

Attitudes Toward Submental Fat Among Adults in the United States.

BACKGROUND: Excess submental fat (SMF) can cause submental fullness resulting in negative perceptions of individuals. However, the impact of SMF on perceptions of social traits has not been well studied. OBJECTIVE: To characterize the impact of SMF on external value judgments in adults in the United States. METHODS: Respondents completed an online survey in which they reacted to statements about individuals with varying grades of SMF. Attributes were rated on a scale from 0 to 100 with higher scores for more positive attributes. RESULTS: Similar proportions of respondents (N = 1996) indicated that women and men with double chins were less attractive than those without (91% and 90%, respectively). A double chin was more likely to be noticed on a woman than on a man (78% of respondents). With increasing SMF, individuals were perceived as significantly less likeable, intelligent, happy, active, and easygoing. Those with greater amounts of SMF were rated as significantly less attractive than those with less SMF. For all attributes, male respondents rated all individuals lower than female respondents did. CONCLUSION: Results from this study provide further evidence of negative perceptions of individuals with SMF. Aesthetics of the submental area, especially SMF, likely impact the overall assessment of attractiveness and social attributes.

ATX-101 (Deoxycholic Acid Injection) Leads to Clinically Meaningful Improvement in Submental Fat: Final Data From CONTOUR.

BACKGROUND: Submental fat (SMF) can negatively affect perceptions of health and attractiveness. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to understand SMF treatment in clinical practice. OBJECTIVE: To report efficacy, treatment characteristics, and safety associated with real-world use of ATX-101 (deoxycholic acid injection). METHODS: CONTOUR enrolled adults considering treatment for SMF reduction. ATX-101-treated patients who completed the end-of-treatment questionnaire were divided into those who ended treatment because they met their treatment goals (n = 197) and those who did not (n = 196). RESULTS: Patients who met their goals (a more defined jawline, looking younger, and looking thinner) were more likely to have less SMF at baseline and to receive ≥2 ATX-101 treatments. More patients who met their goals achieved clinically meaningful reduction in SMF and reported increased satisfaction with their appearance (90% vs 57%). Moderate and severe patients' ATX-101 volume was similar for both those who met goals and those who did not, but extreme patients who met their goals required 10 mL more than those patients who did not. CONCLUSION: Careful patient selection, adequate volume administration, and an appropriate number of treatments (dependent on baseline SMF severity) contribute to successful outcomes with ATX-101.

Understanding the Female African American Facial Aesthetic Patient

BACKGROUND: The patient populations seeking facial aesthetic treatments is expanding in terms of racial, ethnic, and cultural diversity. While treatment of facial aging patterns among white women is well-documented, far less information describes the aesthetic needs of the African American patient. OBJECTIVE: An online study was conducted to survey facial aesthetic concerns and treatment priorities among US-based population of African American women. MATERIALS AND METHODS: A total of 401 female African American participants ages 30 to 65 years reported their attitudes toward facial aging, current facial conditions, most bothersome facial areas and areas most/least likely to be treated first, awareness of treatment options and their consideration rates, and motives and barriers factoring into consideration of injectable treatments. RESULTS: Uneven skin tone/color (57%) and dark circles under the eyes (48%) were the most frequently-reported facial concerns. Other common bothersome facial areas affected by signs of aging were the submental area, periorbital area, forehead lines, and chin. Similarly, areas given greater priority with respect to future treatment included the periorbital area, submental area, and forehead lines. With advancing age, priorities heightened for the mid and lower facial areas, which included the nasolabial folds, chin, and oral commissures. Although the majority of participants would consider injectables, cost, and safety/side effects were cited as frequent concerns. CONCLUSION: For African American women, concerns about facial aging may be less about fine lines and wrinkles caused by increasing skin laxity, and more about pigmentary concerns and shifts in underlying soft tissue volume. J Drugs Dermatol. 2019;18(9):858-866.

Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient's decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

Decades of beauty: Achieving aesthetic goals throughout the lifespan.

BACKGROUND: Several elements, including age, influence judgments of beauty and attractiveness. Aging is affected by intrinsic factors (e.g., genetics, race/ethnicity, anatomical variations) and extrinsic factors (e.g., lifestyle, environment). AIMS: To provide a general overview of minimally invasive injectable procedures for facial beautification and rejuvenation to meet the aesthetic goals of patients across their lifespan, organized by decade. METHODS: This case study review describes aesthetic considerations of females in their third to sixth decade of life (i.e., 20-60 years of age or beyond). Each case study reports the treatments, specifically botulinum toxin type A and soft tissue fillers, used to address aesthetic concerns. RESULTS: Signs of aging, as well as aesthetic goals and motivations, vary by age groups, cultures, and races/ethnicities. However, there are overarching themes that are associated with each decade of life, such as changes in overall facial shape and specific facial regions, which can be used as a starting point for aesthetic treatment planning. Appropriate patient selection, thorough aesthetic evaluation, product knowledge, and injection technique, as well as good physician-patient communication, are essential for optimal treatment outcomes. CONCLUSIONS: Nonsurgical facial injectable treatments can successfully enhance and rejuvenate facial features across different age ranges. A comprehensive understanding of facial aging and the aesthetic considerations of patients by the decade contributes to optimal treatment planning and maintenance.

Submental Area Treatment with ATX-101: Relationship of Mechanism of Action, Tissue Response, and Efficacy.

ATX-101 is an injectable, synthetically derived formulation of deoxycholic acid used for submental fat reduction. Methods: A narrative review of references relevant to the mechanism of action of ATX-101 and its relationship to efficacy and inflammatory adverse events was conducted. Results: When injected into subcutaneous fat, deoxycholic acid physically disrupts adipocyte cell membranes, leading to local adipocytolysis, cell death, and a mild, local inflammatory reaction consisting of macrophage infiltration and fibroblast recruitment. At Day 28 postinjection, inflammation largely resolves, and key histologic features include fibrotic septal thickening, neovascularization, and atrophy of fat lobules. Based on the mechanism of action of ATX-101 and the demonstrated inflammatory response, localized inflammation and swelling are expected following treatment. Indeed, postinjection swelling and other local injection-site events, including pain, erythema, and bruising, are common during and after treatment. Because of inflammatory sequelae following injection, reduction in submental fat is gradual and may require months before the full response is apparent. Patients may also require multiple treatment sessions to achieve their treatment goals. Repeated treatments may result in less pain and swelling over time owing to a combination of factors, including less target tissue allowing for lower doses/injection volumes, persistent numbness, and greater tissue integrity from thickened fibrous septa. Conclusions: Physicians can manage expectations by counseling patients that, based on the mechanism of action of ATX-101 and data from pivotal clinical trials, ATX-101 treatment results in localized inflammation/swelling and gradual submental fat reduction. Patient education about common local adverse events is critical.

Best Clinical Practices with ATX-101 for Submental Fat Reduction: Patient-related Factors and Physician Considerations.

BACKGROUND: Submental fat can be reduced with ATX-101 (deoxycholic acid injection), a customizable and minimally invasive alternative to liposuction. In the years since its approval, the treatment patterns of ATX-101 have evolved. METHODS: A panel of experienced physicians from the United States gathered to generate best practices for the use of ATX-101 in submental contouring. RESULTS: The expert panel provided their insights on appropriate patient selection, managing patient expectations of ATX-101 treatment outcomes, and adverse events, and guidance on ATX-101 administration for optimal outcomes are presented here. CONCLUSION: These best clinical practices on the use of ATX-101 for the reduction of submental fat should enable physicians to enhance the patient treatment experience and outcomes.

Cryolipolysis: Clinical Best Practices and Other Nonclinical Considerations.

Cryolipolysis is a nonsurgical body contouring procedure that involves cooling of fat cells to induce lipolysis while sparing surrounding structures. Plastic surgery practices are increasingly incorporating noninvasive aesthetic procedures (eg, cryolipolysis, fillers, radiofrequency, ultrasound) to offer their patients a wider range of aesthetic treatment options. Here, we report insights from 8 plastic surgeons with regard to cryolipolysis best practices from a clinical perspective and the impact of integrating this noninvasive body contouring procedure into a plastic surgery practice. The authors prefer cryolipolysis over liposuction for patients who are not amenable to surgery or those who desire to avoid downtime, also taking into consideration body mass index, skin laxity, comorbidities, and risk of contour irregularities. Patient counseling is critical for setting realistic expectations regarding outcomes and should focus on the efficacy of cryolipolysis, individual variability in results, potential side effects, time course of treatment response, and the need for multiple treatment cycles. Strategies for reaching new patients and expanding services among current cryolipolysis patients are discussed.

OnabotulinumtoxinA Treatment for Moderate to Severe Forehead Lines: A Review.

With onabotulinumtoxinA approved for the treatment of glabellar and crow's feet lines and, most recently, for forehead lines (FHL), it is possible to simultaneously treat multiple areas of the upper face that are of high concern and treatment priority for aesthetically oriented individuals. This review aims to present key insights on the use of onabotulinumtoxinA for the treatment of moderate to severe FHL. METHODS: Double-blind, placebo-controlled registration trials of onabotulinumtoxinA for the treatment of FHL were included. Using findings from 3 such published studies, we discuss key concepts and clinical experience for the treatment of moderate to severe FHL with onabotulinumtoxinA (20 U in the frontalis and 20 U in the glabellar complex, with/without 24 U in crow's feet lines), including injection pattern, dose selection, efficacy and safety data, and considerations for patient selection. RESULTS: Across the 2 pivotal phase 3 studies, responder rates on investigator- and subject-assessed measures of appearance of FHL severity were significantly higher with onabotulinumtoxinA versus placebo for the treatment of FHL at day 30 (P < 0.0001), and results were maintained through 3 cycles of onabotulinumtoxinA. CONCLUSIONS: OnabotulinumtoxinA treatment also resulted in high patient satisfaction rates. The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected. OnabotulinumtoxinA is safe and effective and an appropriate option for patients with moderate to severe FHL encountered in clinical practice.