Arthur Swift

The Long‐Term Efficacy and Safety of a Subcutaneously Injected Large‐Particle Stabilized Hyaluronic Acid–Based Gel of NonAnimal Origin in Esthetic Facial Contouring

BACKGROUND Nonanimal stabilized hyaluronic acid (NASHA) offers longer‐lasting correction than many other injectable products and is associated with low risk of immunogenic and hypersensitivity reactions. A new large‐particle stabilized hyaluronic acid–based gel has been developed to restore facial volume and define facial contours. OBJECTIVE This study was conducted to assess the long‐term efficacy and safety of a large‐particle stabilized hyaluronic acid–based gel in patients seeking facial contouring. METHODS Fifty‐seven adult patients seeking esthetic cheek or chin augmentation or both received subcutaneous or supraperiosteal injections or both of large‐particle stabilized hyaluronic acid–based gel (20 mg/mL). Efficacy was assessed subjectively using the Global Aesthetic Improvement Scale at intervals up to 12 months after treatment. RESULTS After treatment, patients and investigators independently considered treatment sites to be at least somewhat improved in 91% and 96% (6 months), 68% and 77% (9 months), and 58% and 52% (12 months) of cases, respectively. Patient‐ and investigator‐assessed treatment response rates (the proportion of patients showing at least moderate improvement) were 72% and 81% (6 months), 42% and 40% (9 months), and 21% and 15% (12 months), respectively. Most commonly reported adverse events were local injection‐site reactions, skin induration, and implant mobility. CONCLUSION This large‐particle stabilized hyaluronic acid–based gel is well tolerated and provides relatively long‐lasting esthetic correction of the cheeks and chin after subcutaneous or supraperiosteal injection. Claudio DeLorenzi, MD, Michael Weinberg, MD, Nowell Solish, MD and Arthur Swift, MD, have been consultants to both Medicis Inc. and Q‐Med AB, and have received payment for clinical research and training preceptorships. Q‐Med AB provided the material used, and the authors (investigators) were paid for their parcticipation in the study.

The evolving role of hyaluronic acid fillers for facial volume restoration and contouring: a Canadian overview

Recent advancements, including more versatile facial fillers, refined injection techniques and the adoption of a global facial approach, have contributed to improved patient outcome and increased patient satisfaction. Nine Canadian specialists (eight dermatologists, one plastic surgeon) collaborated to develop an overview on volume restoration and contouring based on published literature and their collective clinical experience. The specialists concurred that optimal results in volume restoration and contouring depend on correcting deficiencies at various layers of the facial envelope. This includes creating a foundation for deep structural support in the supraperiosteal or submuscular plane; volume repletion of subcutaneous fat compartments; and the reestablishment of dermal and subdermal support to minimize cutaneous rhytids, grooves and furrows. It was also agreed that volume restoration and contouring using a global facial approach is essential to create a natural, youthful appearance in facial aesthetics. A comprehensive non-surgical approach should therefore incorporate combining fillers such as high-viscosity, low-molecular-weight hyaluronic acid (LMWHA) for structural support and hyaluronic acid (HA) for lines, grooves and furrows with neuromodulators, lasers and energy devices.

Upper Face: Clinical Anatomy and Regional Approaches with Injectable Fillers.

Background: The use of facial fillers has been rapidly increased as the range of injectable products and indications continues to expand. Complications may arise from improper placement or technique. This article highlights the importance of anatomic knowledge when using injectable fillers in the face. Methods: A detailed review of the clinical anatomy of the upper face is performed. Regional approaches are described using the applied anatomy to efficiently and safely augment the different subunits of the upper face. Results: Key aspects of safe and successful injection of fillers in the upper face include a thorough knowledge of the location of fat compartments and neurovascular structures. Awareness of these structures enables the practitioner to maximize injections, while avoiding damage to important nerves and vessels. Conclusion: A detailed knowledge of the anatomy and properties of the product is paramount to maximize the efficacy while minimizing the risk of complications.

Global Aesthetics Consensus: Avoidance and Management of Complications from Hyaluronic Acid Fillers—evidence- and Opinion-based Review and Consensus Recommendations

Background: Although the safety profile of hyaluronic acid fillers is favorable, adverse reactions can occur. Clinicians and patients can benefit from ongoing guidance on adverse reactions to hyaluronic acid fillers and their management. Methods: A multinational, multidisciplinary group of experts in cosmetic medicine convened the Global Aesthetics Consensus Group to review the properties and clinical uses of Hylacross and Vycross hyaluronic acid products and develop updated consensus recommendations for early and late complications associated with hyaluronic acid fillers. Results: The consensus panel provided specific recommendations focusing on early and late complications of hyaluronic acid fillers and their management. The impact of patient-, product-, and technique-related factors on such reactions was described. Most of these were noted to be mild and transient. Serious adverse events are rare. Early adverse reactions to hyaluronic acid fillers include vascular infarction and compromise; inflammatory reactions; injection-related events; and inappropriate placement of filler material. Among late reactions are nodules, granulomas, and skin discoloration. Most adverse events can be avoided with proper planning and technique. Detailed understanding of facial anatomy, proper patient and product selection, and appropriate technique can further reduce the risks. Should adverse reactions occur, the clinician must be prepared and have tools available for effective treatment. Conclusions: Adverse reactions with hyaluronic acid fillers are uncommon. Clinicians should take steps to further reduce the risk and be prepared to treat any complications that arise.

Safety and effectiveness of large gel particle hyaluronic acid with lidocaine for correction of midface volume loss.

BACKGROUND Midface volume loss and contour deficiency are often treated using soft‐tissue fillers capable of elevating and supporting facial features. OBJECTIVE To evaluate the effectiveness and safety of large gel particle hyaluronic acid with 0.3% lidocaine (LGP‐HA‐L) for the treatment of midface volume loss or contour deficiency. METHODS AND MATERIALS This 24‐week, open‐label study recruited adults aged 18 to 65 with bilateral moderate to substantial midface volume loss or contour deficiency (Medicis Midface Volume Scale (MMVS) score 3–4). The primary effectiveness measure was MMVS response (≥1‐grade improvement) 8 weeks after treatment according to evaluators blinded to injection volume. RESULTS All enrolled patients (n = 40; 85.0% female; mean ± SD age 53.1 ± 7.0 years) completed the study. Mean ± SD injected volume for both sides of the midface was 5.3 ± 2.5 mL. Week 8 MMVS response rates were 97.5% according to blinded evaluators and treating investigators and 90.0% according to patients; week 24 rates were 90.0%, 92.5%, and 82.5%, respectively. Global Aesthetic Improvement Scale response rates were 95.0% to 100.0% throughout the study. Adverse events were reported in 60.0% of patients and were mild or moderate; all resolved by study end and most within 1 week. CONCLUSION Midface volume loss or contour deficiency may be safely and effectively corrected using LGP‐HA‐L.

Global Aesthetics Consensus: Hyaluronic Acid Fillers and Botulinum Toxin Type A-Recommendations for Combined Treatment and Optimizing Outcomes in Diverse Patient Populations.

Background: Combination of fillers and botulinum toxin for aesthetic applications is increasingly popular. Patient demographics continue to diversify, and include an expanding population receiving maintenance treatments over decades. Methods: A multinational panel of plastic surgeons and dermatologists convened the Global Aesthetics Consensus Group to develop updated guidelines with a worldwide perspective for hyaluronic acid fillers and botulinum toxin. This publication considers strategies for combined treatments, and how patient diversity influences treatment planning and outcomes. Results: Global Aesthetics Consensus Group recommendations reflect increased use of combined treatments in the lower and upper face, and some midface regions. A fully patient-tailored approach considers physiologic and chronologic age, ethnically associated facial morphotypes, and aesthetic ideals based on sex and culture. Lower toxin dosing, to modulate rather than paralyze muscles, is indicated where volume deficits influence muscular activity. Combination of toxin with fillers is appropriate for several indications addressed previously with toxin alone. New scientific data regarding hyaluronic acid fillers foster an evidence-based approach to selection of products and injection techniques. Focus on aesthetic units, rather than isolated rhytides, optimizes results from toxin and fillers. It also informs longitudinal treatment planning, and analysis of toxin nonresponders. Conclusions: The emerging objective of injectable treatment is facial harmonization rather than rejuvenation. Combined treatment is now a standard of care. Its use will increase further as we refine the concept that aspects of aging are intimately related, and that successful treatment entails identifying and addressing the primary causes of each. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Facial Assessment and Injection Guide for Botulinum Toxin and Injectable Hyaluronic Acid Fillers: Focus on the Midface

This third article of a three-part series addresses techniques and recommendations for aesthetic treatment of the lower face. The lower face is considered an advanced area for facial aesthetic treatment. In this region, soft-tissue fillers play a more important role than neuromodulators and should be used first to provide structure and support before neuromodulators are considered for treatment of dynamic lines. Treatment of the lip, perioral region, and chin, in addition to maintaining balance of the lower face with the face overall, is challenging. Procedures on the lip should avoid overcorrection while respecting the projection of the lips on the profile view and the ratio of lip size to chin. The chin is often neglected, but reshaping the jawline can provide dramatic improvement in facial aesthetics. Both profile and anterior views are critical in assessment and treatment of the lower face. Finally, rejuvenation of the neck region requires fillers for structural support of the chin and jawline and neuromodulators for treatment of the masseter and platysma.

Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo

BACKGROUND Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment.

BACKGROUND Juvéderm Voluma XC (VYC-20L; hyaluronic acid gel) is approved in the United States for correction of age-related midface volume deficit (MVD). OBJECTIVE Assess safety and effectiveness of VYC-20L after repeat treatment. METHODS Subjects with MVD underwent optional repeat treatment 12 to 24 months after initial treatment if correction was lost or at 24 months regardless of loss of correction (n = 167). Investigators rated outcomes on the Mid-Face Volume Deficit Scale (MFVDS) and the Global Aesthetic Improvement Scale (GAIS). Subject-rated outcomes were the GAIS, overall satisfaction with facial appearance, achievement of treatment goal, and Self-Perception of Age questionnaire. Subjects recorded treatment-site responses in 30-day diaries. RESULTS Mean injection volume for repeat treatment (3.13 mL) was approximately half the mean total injection volume for initial/touch-up treatment (6.8 mL). After repeat treatment, effectiveness was demonstrated on all investigator-rated and subject-rated measures, consistent with results observed after initial treatment. The percentage of subjects improving by ≥1 point on the MFVDS was 82.8% and 91.1% at 6 and 12 months after repeat treatment, respectively. The incidence, severity, and duration of common treatment-site responses were lower after repeat versus initial treatment. CONCLUSION Repeat treatment with VYC-20L was well tolerated and resulted in high levels of effectiveness and subject satisfaction.

OnabotulinumtoxinA and Hyaluronic Acid in Facial Wrinkles and Folds: A Prospective, Open-Label Comparison

Background OnabotulinumtoxinA and hyaluronic acid are effective in improving moderate to severe facial wrinkles and folds, with treatment selection traditionally based upon facial area. Objectives This prospective, multicenter, open-label, crossover study evaluated physician-rated efficacy and patient-rated outcomes following moderate to severe facial wrinkles and folds treatment with onabotulinumtoxinA and hyaluronic acid. Methods 152 subjects (25-65 years) were randomized (1:1) to a treatment-sequence of onabotulinumtoxinA/hyaluronic acid or hyaluronic acid/onabotulinumtoxinA, with initial treatment administered on day 1 and 6 additional visits: week 2 (touch-up); week 4 (crossover); week 6 (touch-up); and weeks 8, 12, and 24 (follow-up). Results Between 92% and 100% of subjects in each treatment-sequence group exhibited at least some improvement from baseline at each study visit in the Physician Aesthetic Improvement Scale and the Objective Observer and Patient Global Assessments of Improvement, with no significant between-sequence differences. Subjects reported looking 3 to 6 years younger at each visit, with significant improvements in glabellar, lateral canthal, and horizontal forehead lines, and nasolabial folds. Treatments were well tolerated. Conclusions OnabotulinumtoxinA and hyaluronic acid provide clinically meaningful improvements as rated by physicians, objective observers, and subjects, with clinical synergy in aesthetic effects and duration of response regardless of treatment administration order in subjects seeking improvement in moderate to severe facial wrinkles and folds. Level of Evidence 2