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.

Global Aesthetics Consensus: Botulinum Toxin Type A--Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications.

BACKGROUND: Botulinum toxin type A injection remains the leading nonsurgical cosmetic procedure worldwide, with a high rate of efficacy and patient satisfaction. METHODS: A multinational, multidisciplinary group of plastic surgeons and dermatologists convened the Global Aesthetics Consensus Group to develop updated consensus recommendations with a worldwide perspective for botulinum toxin and hyaluronic acid fillers. This publication on botulinum toxin type A considers advances in facial analysis, injection techniques, and avoidance and management of complications. RESULTS: Use of botulinum toxin has evolved from the upper face to also encompass the lower face, neck, and midface. The Global Aesthetics Consensus Group emphasizes an integrative, diagnostic approach. Injection dosage and placement are based on analysis of target muscles in the context of adjacent ones and associated soft and hard tissues. The indication for selection of botulinum toxin as a primary intervention is that excessive muscular contraction is the primary etiology of the facial disharmony to be addressed. Global Aesthetics Consensus Group recommendations demonstrate a paradigm shift toward neuromodulation rather than paralysis, including lower dosing of the upper face, more frequent combination treatment with hyaluronic acid fillers, and intracutaneous injection where indicated to limit depth and degree of action. CONCLUSIONS: The accumulation of clinical evidence and experience with botulinum toxin has led to refinements in treatment planning and implementation. The Global Aesthetics Consensus Group advocates an etiology-driven, patient-tailored approach, to enable achievement of optimal efficacy and safety in patient populations that are rapidly diversifying with respect to ethnicity, gender, and age. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Eiffel Tower Nose-Lift: Anatomical Basis and Concepts for Safe and Effective Nasal Injections.

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Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study.

BACKGROUND: Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement. OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®). METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥ 1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment. RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P ≤ .03), perioral lines (P ≤ .04), and oral commissures (P ≤ .03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler. CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.

Evolution of Facial Aesthetic Treatment Over Five or More Years: A Retrospective Cross-sectional Analysis of Continuous OnabotulinumtoxinA Treatment.

BACKGROUND: Little information exists on how facial aesthetic treatments are incorporated into aesthetic regimens. OBJECTIVE: Assess the evolution of facial aesthetic treatments in patients receiving long-term continuous onabotulinumtoxinA treatment. METHODS: This international retrospective chart review included patients with ≥5 years of continuous onabotulinumtoxinA treatments including ≥1 glabellar lines treatment/year. Charts were reviewed for facial areas treated, number of treatments, doses/treatment visit, concomitant aesthetic procedures, and onabotulinumtoxinA-related adverse events. RESULTS: Data were collected from 5,112 onabotulinumtoxinA treatment sessions for 194 patients over an average of 9.1 years. Dosing was relatively stable over time; however, interinjection intervals increased. Glabellar lines' treatment temporally preceded crow's feet lines and forehead lines' treatment. A majority of patients (85%) also received treatment with fillers. Cumulative increases in onabotulinumtoxinA treatments occurred over time and by facial area corresponding with increases in treatments with injectable fillers, energy-based devices, and prescription topical creams. The longer the patients were treated, the younger they perceived themselves to look. Rates of adverse events were low. CONCLUSION: OnabotulinumtoxinA treatment evolved over time, coinciding with growth of the facial aesthetics market. Additional treatment modalities were added as complements to onabotulinumtoxinA. Long-term continuous onabotulinumtoxinA injections are an important component of contemporary facial aesthetic treatment regimens.

Juvéderm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial.

BACKGROUND: Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler. METHODS: In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan's Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scales. Subjects evaluated outcomes using the FACE-Q Recovery Early Life Impact and Recovery Early Symptoms modules. The primary endpoint was noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L based on responder rate (percentage of subjects with ≥1-point Lip Fullness Scale improvement at month 3 ICR assessment vs baseline). RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L. Although responder rates based on ICR assessments of lip fullness, perioral lines, and oral commissures did not differ between treatments, investigator assessments showed significant improvements in perioral lines and oral commissures with Juvéderm Volbella with Lidocaine vs Restylane-L (P ≤ 0.029). Subjects treated with Juvéderm Volbella with Lidocaine had higher mean FACE-Q scores on day 1 (P ≤ 0.001), indicating less disruption of daily activities. Mean change in lip volume from baseline to day 1 was smaller in the Juvéderm Volbella with Lidocaine group (but similar between treatments on day 14), indicating less acute swelling. Severe injection site responses occurred less frequently with Juvéderm Volbella with Lidocaine. CONCLUSIONS: Juvéderm Volbella with Lidocaine is effective for lip enhancement, improves perioral lines and oral commissures, and results in less short-term swelling and disruption in daily activities than Restylane-L.

Global 3-dimensional approach to natural rejuvenation: recommendations for perioral, nose, and ear rejuvenation.

BACKGROUND: There is a move toward a global, 3-dimensional approach to facial rejuvenation that has been prompted by advances in techniques and available products. However, little published literature exists on the procedures involved in this global approach, and currently, no validated recommendations exist. OBJECTIVES: To provide a detailed, practical guide to rejuvenation of the perioral area, nose, and ears based on expert consensus recommendations. METHODS: The aim of this approach was to take into account both volumetric and dynamic aspects of treatment, as well as the benefits of treatment combinations, for example, combining botulinum toxins with hyaluronic acid (HA) fillers and volumizers. Each set of recommendations was documented, comprising a clinical definition of the aging severity scale, together with recommendations of appropriate products, doses, site, depth, and injection techniques, as well as indication-specific rules to be respected. RESULTS: HA fillers are ideal for replenishing volume loss in the lips, while rhytides around the lips can be treated with small doses of botulinum toxin. Botulinum toxin can also be used to raise the tip of the nose, to reshape nostrils, and to narrow nasal flare, with HA fillers also be used to correct small defects. HA fillers can also be used to rejuvenate sagging, atrophic or irregular ear lobes, repair torn earlobes, or erase vertical rhytides. CONCLUSIONS: By providing practical guidance on rejuvenation of the perioral area, nose, and ears, esthetic facial physicians can achieve optimum patient outcomes.

Global, 3-dimensional approach to natural rejuvenation: part 1 - recommendations for volume restoration and the periocular area.

BACKGROUND: New techniques and products have lead to a global approach for the treatment of signs of aging. However, there is little published literature on the procedures involved in this approach and currently no validated recommendations exist. OBJECTIVES: To provide a detailed, practical guide to midfacial volume restoration and rejuvenation of the periocular area based on expert consensus recommendations. METHODS: The expert committee took into account both volumetric and dynamic aspects of treatment, as well as benefits of treatment combinations, for example, combining OnabotulinumtoxinA with hyaluronic acid (HA) fillers and volumizers. An aging severity scale was established for each area, together with recommendations of appropriate products, doses, site, depth, and injection techniques, as well as rules to be respected. RESULTS: The expert group concluded that volume restoration of the midface is the first essential step in the global approach because treatment for this area has the most significant positive impact. Firstly, it is important to restore the malar contour, as malar volume anchors the structure of the midface. Secondly, an assessment of the effects of malar enhancement on the appearance of the nasolabial folds and the nasojugal fold (tear trough) should be conducted because these aging signs may be decreased by malar enhancement. Finally, treatment for the nasolabial folds and periorbital area with HA should be performed when needed. CONCLUSIONS: Practical guidance is provided for midfacial volume restoration and rejuvenation of the periocular area based on validated expert consensus recommendations. This will help esthetic facial physicians to achieve optimum outcomes.

Lower-face and neck antiaging treatment and prevention using onabotulinumtoxin A: the 2010 multidisciplinary French consensus--part 2.

BACKGROUND: Onabotulinumtoxin A has been used for many years in the aging face treatment. A survey was organized to identify current practices in France. OBJECTIVE: To develop consensual recommendations for treating aging lower face and neck with onabotulinumtoxin A. METHODS AND MATERIALS: Fifty-seven participants to six regional surveys reviewed practices and techniques for each individual treatment indication. From conference summaries and data from a questionnaire, consensual recommendations were developed. RESULTS: General considerations, key treatment rules, injection specifics (dose, site, and techniques), associated procedures/treatments, and procedure follow-up were defined by indication, i.e., nasolabial angle, nasal tip repositioning, dilated nostrils, lips and perioral area, Marionette lines and depressor anguli oris, gingival smile, risorius and zygomatic perioral muscles, masseters, chin, and platysma. For the consensus participants, current onabotulinumtoxin A use is a global preventive and corrective treatment. Overall, judicious treatment of multiple sites and adjunctive modalities, such as fillers, peels, and laser, leads to satisfactory results with a youthful, harmonious, animated, and natural-looking face. CONCLUSION: Years of experience using onabotulinumtoxin A result in sophisticated treatment approaches, more specific targeted injections, and better understanding of lower facial and neck aging, leading to satisfying therapeutic results for patients and clinicians.

How to achieve synergy between volume replacement and filling products for global facial rejuvenation.

The objective of this paper is to provide an expert consensus regarding facial rejuvenation using a combination of volume replacement (Juvéderm(®) VOLUMA(®)), filling products (Juvéderm(®) Ultra product line) and botulinum toxin. The Juvéderm product line exploits innovative 3-D technology, producing a range of cohesive, homogenous gels that produce predictable, long-lasting and natural results. The products are easy to use by practitioners and are well-tolerated by patients, and used in combination can provide additional benefits not achieved with one product alone. An assessment of facial anatomy and consideration of the aging process, as well as available treatment options, are also addressed in determining the best combination of products to use. Outcomes from a questionnaire and workshop sessions focusing on specific aspects of use of the Juvéderm product line and botulinum toxin in daily clinical practice are discussed, and recommendations for product use following debate amongst the experts are provided.

Upper- and mid-face anti-aging treatment and prevention using onabotulinumtoxin A: the 2010 multidisciplinary French consensus--part 1.

BACKGROUND: Onabotulinumtoxin A (onabotulinum) has been used for 7 years in the treatment of the aging face. A survey was conducted to identify current practices in France. OBJECTIVE: To develop consensual practice recommendations for treating the aging upper- and mid-face with onabotulinum. METHODS AND MATERIALS: Fifty-seven participants reviewed practices and techniques for each identified upper- and mid-face treatment indication. From data gathered during six regional conferences and from a questionnaire, consensual recommendations were developed. RESULTS: General considerations, key treatment rules, injection specifics (dose, site, and techniques), associated procedures/treatments, and follow-up were defined for each indication, i.e., glabellar, horizontal forehead, crow's feet and bunny lines, lower eyelid rhytides, and eyebrow repositioning and reshaping. For the consensus participants, current onabotulinum use is a global, both preventive and corrective treatment. In France, judicious lowest effective dose, treatment of multiple sites and adjunctive treatment modalities, such as fillers and peels, lead to satisfactory results for clinicians and patients with a youthful, harmonious, animated and natural looking face. CONCLUSIONS: Years of experience using onabotulinum result in sophisticated treatment approaches, more specific targeted injections, and a better understanding of facial aging, leading to satisfying therapeutic results for both patients and clinicians.

Longevity of effects of hyaluronic acid plus lidocaine facial filler.

BACKGROUND: A new hyaluronic acid filler containing pre-incorporated 0.3% lidocaine reduces pain and enhances patient comfort. In vitro studies confirm functional equivalence with non-lidocaine-containing products, but only limited data are available on the long-term effects of lidocaine on filler performance in the clinical setting. AIMS: To investigate whether inclusion of lidocaine impacts the longevity of hyaluronic acid fillers. PATIENTS/METHODS: 60 patients with moderate-severe bilateral nasolabial folds received 24 mg/mL hyaluronic acid with pre-incorporated lidocaine or an equivalent product without lidocaine and were followed-up for up to 76 weeks. RESULTS: Significantly better results were found in favor of HA gel with pre-incorporated lidocaine for physician assessment of injection pain and patient pain assessment after injection (both P < 0.001). Long-term follow-up of patients after almost a year showed that 91% (52/57) of patients had no evidence of facial asymmetry, and investigators confirmed lidocaine had no effect on filler longevity. High levels of patient satisfaction and prolonged benefits due to persistence of the product were noted, with those patients needing additional treatment requiring 'top-up' rather than full re-treatment. CONCLUSIONS: The addition of 0.3% lidocaine does not affect product longevity and the small volume required for 'touch-up' also suggests that longevity is maintained.

A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds.

This split-face, single-blind study compared the comfort and ease of injection of a new hyaluronic acid facial filler containing pre-incorporated lidocaine (Juvederm ULTRA 3) versus the established hyaluronic acid facial filler Restylane-Perlane. A total of 126 individuals were treated with both products, randomly assigned to the right or left naso-labial fold. Injector assessment-indicated mean injection pain, pain of massaging the injected area and post-injection discomfort (based on a scale of 0=no pain to 10=extreme pain) were 2.1, 0.9 and 0.4 for Juvederm ULTRA 3, and 4.1, 3.3 and 1.7 for Restylane-Perlane, respectively (p<0.0001). Patient assessment of the same parameters were 2.8, 1.3 and 0.4 for Juvederm ULTRA 3, and 4.9, 3.6 and 1.8 for Restylane-Perlane (p<0.0001). Injectors indicated that 92% of Juvederm ULTRA 3 injections were 'very easy', compared with 21% for Restylane-Perlane. Post-treatment smoothness was comparable, but 95% of individuals preferred Juvederm ULTRA 3 for overall injection comfort. A total of 95% of individuals indicated that Juvederm ULTRA 3 was a more comfortable and gentle experience.

Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and a hyaluronic acid filler alone.

BACKGROUND: A smooth, cohesive, 24-mg/mL hyaluronic acid (HA) gel with uniform consistency, even flow characteristics, and extended duration was designed for injection into the mid to deep dermis. OBJECTIVE: To compare injection pain of a HA gel with preincorporated lidocaine with that with a non-lidocaine formulation. METHODS & MATERIALS: This double-blind study at three centers enrolled 60 subjects, injected with both products, randomly assigned to left or right nasolabial fold. The injecting physician assessed severity of pain and ease of injection. Subjects used a visual analog scale (0-10) for pain assessment. Adverse events were recorded. RESULTS Physician assessment of injection pain was none or mild in 81% of HA gel injections with preincorporated lidocaine and 36% of HA-alone injections (p<.001). Mean pain assessment by subjects was 3.6 for HA+lidocaine and 5.8 for HA alone (p<.001). Ninety-five percent of the injections were considered easy or very easy; a greater percentage of HA+lidocaine injections were rated very easy. Mild to moderate adverse events were reported for both products. CONCLUSION: The smooth, cohesive HA gel with preincorporated lidocaine increased subject comfort during treatment and improved the injection experience.

Volumizing effect of a new hyaluronic acid sub-dermal facial filler: a retrospective analysis based on 102 cases.

INTRODUCTION: Many signs of aging are due to the loss of subcutaneous fat. Dermal fillers are non-surgical cosmetic treatments used to restore facial volume. Voluma is a new hyaluronic acid sub-dermal facial filler. The objective of this study was to assess its effectiveness in maintaining increased volume for up to 18 months post-treatment and its safety. METHODS: Retrospective record analysis was made for 102 patients (93 females, nine males; mean age: 51.27 years) who received Voluma injected into the midface. All patients were assessed at baseline and at 1 month and 6-18 months post-injection. RESULTS: Investigator Global Aesthetic Improvement assessment after 1 month and 6-18 months showed that most patients were 'much' or 'very much' improved. Investigator volume loss assessment confirmed that most patients were either stage 1 or 2 (normal or slight ptosis) 1 month post-treatment, which was maintained at 6-18 months. Patient efficacy assessment was 'very good' or 'good' in most cases. CONCLUSIONS: Voluma provides aesthetic improvements according to investigator and patient assessment for up to 18 months post-treatment. Combination treatment comprising facial fillers and botulinum neurotoxin can enhance treatment benefits. Further methodologically rigorous studies are required to establish the performance of Voluma alone and in combination.

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.

Facial rejuvenation with botulinum neurotoxin: an anatomical and experiential perspective.

The utilization of botulinum neurotoxin for facial rejuvenation has been progressively expanding into multiple upper, mid, and lower facial and neck applications. Success in these areas is dependent upon a number of factors, above all a sophisticated understanding of the underlying facial anatomy. In addition, although published consensus recommendations can guide dosing and injection site placement, expert technical application is critical, as is individualized treatment for each patient, based on an aesthetic assessment. This includes an evaluation of the patient's unique functional anatomy and a frank discussion of the patient's desires and goals. Only by addressing these considerations can the best possible outcomes be consistently achieved.