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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Global Aesthetics Consensus: Botulinum Toxin Type A—Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications</title>
<author><name sortKey="Sundaram, Hema" sort="Sundaram, Hema" uniqKey="Sundaram H" first="Hema" last="Sundaram">Hema Sundaram</name>
</author>
<author><name sortKey="Signorini, Massimo" sort="Signorini, Massimo" uniqKey="Signorini M" first="Massimo" last="Signorini">Massimo Signorini</name>
</author>
<author><name sortKey="Liew, Steven" sort="Liew, Steven" uniqKey="Liew S" first="Steven" last="Liew">Steven Liew</name>
</author>
<author><name sortKey="Trindade De Almeida, Ada R" sort="Trindade De Almeida, Ada R" uniqKey="Trindade De Almeida A" first="Ada R." last="Trindade De Almeida">Ada R. Trindade De Almeida</name>
</author>
<author><name sortKey="Wu, Yan" sort="Wu, Yan" uniqKey="Wu Y" first="Yan" last="Wu">Yan Wu</name>
</author>
<author><name sortKey="Vieira Braz, Andre" sort="Vieira Braz, Andre" uniqKey="Vieira Braz A" first="André" last="Vieira Braz">André Vieira Braz</name>
</author>
<author><name sortKey="Fagien, Steven" sort="Fagien, Steven" uniqKey="Fagien S" first="Steven" last="Fagien">Steven Fagien</name>
</author>
<author><name sortKey="Goodman, Greg J" sort="Goodman, Greg J" uniqKey="Goodman G" first="Greg J." last="Goodman">Greg J. Goodman</name>
</author>
<author><name sortKey="Monheit, Gary" sort="Monheit, Gary" uniqKey="Monheit G" first="Gary" last="Monheit">Gary Monheit</name>
</author>
<author><name sortKey="Raspaldo, Herve" sort="Raspaldo, Herve" uniqKey="Raspaldo H" first="Hervé" last="Raspaldo">Hervé Raspaldo</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">26910696</idno>
<idno type="pmc">5242214</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5242214</idno>
<idno type="RBID">PMC:5242214</idno>
<idno type="doi">10.1097/01.prs.0000475758.63709.23</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">002C87</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002C87</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Global Aesthetics Consensus: Botulinum Toxin Type A—Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications</title>
<author><name sortKey="Sundaram, Hema" sort="Sundaram, Hema" uniqKey="Sundaram H" first="Hema" last="Sundaram">Hema Sundaram</name>
</author>
<author><name sortKey="Signorini, Massimo" sort="Signorini, Massimo" uniqKey="Signorini M" first="Massimo" last="Signorini">Massimo Signorini</name>
</author>
<author><name sortKey="Liew, Steven" sort="Liew, Steven" uniqKey="Liew S" first="Steven" last="Liew">Steven Liew</name>
</author>
<author><name sortKey="Trindade De Almeida, Ada R" sort="Trindade De Almeida, Ada R" uniqKey="Trindade De Almeida A" first="Ada R." last="Trindade De Almeida">Ada R. Trindade De Almeida</name>
</author>
<author><name sortKey="Wu, Yan" sort="Wu, Yan" uniqKey="Wu Y" first="Yan" last="Wu">Yan Wu</name>
</author>
<author><name sortKey="Vieira Braz, Andre" sort="Vieira Braz, Andre" uniqKey="Vieira Braz A" first="André" last="Vieira Braz">André Vieira Braz</name>
</author>
<author><name sortKey="Fagien, Steven" sort="Fagien, Steven" uniqKey="Fagien S" first="Steven" last="Fagien">Steven Fagien</name>
</author>
<author><name sortKey="Goodman, Greg J" sort="Goodman, Greg J" uniqKey="Goodman G" first="Greg J." last="Goodman">Greg J. Goodman</name>
</author>
<author><name sortKey="Monheit, Gary" sort="Monheit, Gary" uniqKey="Monheit G" first="Gary" last="Monheit">Gary Monheit</name>
</author>
<author><name sortKey="Raspaldo, Herve" sort="Raspaldo, Herve" uniqKey="Raspaldo H" first="Hervé" last="Raspaldo">Hervé Raspaldo</name>
</author>
</analytic>
<series><title level="j">Plastic and Reconstructive Surgery</title>
<idno type="ISSN">0032-1052</idno>
<idno type="eISSN">1529-4242</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background:</title>
<p>Botulinum toxin type A injection remains the leading nonsurgical cosmetic procedure worldwide, with a high rate of efficacy and patient satisfaction.</p>
</sec>
<sec><title>Methods:</title>
<p>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.</p>
</sec>
<sec><title>Results:</title>
<p>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.</p>
</sec>
<sec><title>Conclusions:</title>
<p>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.</p>
</sec>
<sec><title>CLINCAL QUESTION/LEVEL OF EVIDENCE:</title>
<p>Therapeutic, V.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Plast Reconstr Surg</journal-id>
<journal-id journal-id-type="iso-abbrev">Plast. Reconstr. Surg</journal-id>
<journal-id journal-id-type="publisher-id">PRS</journal-id>
<journal-title-group><journal-title>Plastic and Reconstructive Surgery</journal-title>
</journal-title-group>
<issn pub-type="ppub">0032-1052</issn>
<issn pub-type="epub">1529-4242</issn>
<publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26910696</article-id>
<article-id pub-id-type="pmc">5242214</article-id>
<article-id pub-id-type="art-access-id">00010</article-id>
<article-id pub-id-type="doi">10.1097/01.prs.0000475758.63709.23</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Cosmetic: Original Articles</subject>
</subj-group>
</article-categories>
<title-group><article-title>Global Aesthetics Consensus: Botulinum Toxin Type A—Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Sundaram</surname>
<given-names>Hema</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Signorini</surname>
<given-names>Massimo</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Liew</surname>
<given-names>Steven</given-names>
</name>
<degrees>M.B.B.S., M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Trindade de Almeida</surname>
<given-names>Ada R.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Wu</surname>
<given-names>Yan</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Vieira Braz</surname>
<given-names>André</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Fagien</surname>
<given-names>Steven</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Goodman</surname>
<given-names>Greg J.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Monheit</surname>
<given-names>Gary</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Raspaldo</surname>
<given-names>Hervé</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<aff>Rockville, Md.; Milan, Italy; Sydney, New South Wales, and Carlton, Victoria, Australia; São Paolo and Rio de Janeiro, Brazil; Beijing, China; Boca Raton, Fla.; Seoul, Korea; and Cannes, France</aff>
</contrib-group>
<contrib-group><contrib contrib-type="author"><collab>Global Aesthetics Consensus Group</collab>
</contrib>
</contrib-group>
<author-notes><corresp id="c1">Hema Sundaram, M.D., 11119 Rockville Pike, Suite 205, Rockville, Md. 20852, <email xlink:href="hemasundaram@gmail.com">hemasundaram@gmail.com</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>3</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub"><day>25</day>
<month>2</month>
<year>2016</year>
</pub-date>
<volume>137</volume>
<issue>3</issue>
<fpage>518</fpage>
<lpage>529</lpage>
<history><date date-type="received"><day>2</day>
<month>6</month>
<year>2015</year>
</date>
<date date-type="accepted"><day>21</day>
<month>7</month>
<year>2015</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2016 by the American Society of Plastic Surgeons</copyright-statement>
<copyright-year>2016</copyright-year>
</permissions>
<self-uri xlink:type="simple" xlink:href="prs-137-518e.pdf"></self-uri>
<abstract><sec><title>Background:</title>
<p>Botulinum toxin type A injection remains the leading nonsurgical cosmetic procedure worldwide, with a high rate of efficacy and patient satisfaction.</p>
</sec>
<sec><title>Methods:</title>
<p>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.</p>
</sec>
<sec><title>Results:</title>
<p>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.</p>
</sec>
<sec><title>Conclusions:</title>
<p>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.</p>
</sec>
<sec><title>CLINCAL QUESTION/LEVEL OF EVIDENCE:</title>
<p>Therapeutic, V.</p>
</sec>
</abstract>
<custom-meta-group><custom-meta><meta-name>STATUS</meta-name>
<meta-value>ONLINE-ONLY</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
<body><fig id="FU1" position="anchor"><graphic xlink:href="prs-137-518e-g001"></graphic>
</fig>
<p>Botulinum toxin type A injection is the most common cosmetic procedure globally. Surveys from core aesthetic specialty organizations consistently rank it first on lists of member-reported, nonsurgical aesthetic procedures. In 2014, the American Society for Aesthetic Plastic Surgery reported more than 3.5 million botulinum toxin procedures.<sup><xref rid="R1" ref-type="bibr">1</xref>
</sup>
The International Society of Aesthetic Plastic Surgery survey reported more than 4.8 million procedures worldwide in 2014,<sup><xref rid="R2" ref-type="bibr">2</xref>
</sup>
and the 2013 American Society for Dermatologic Surgery survey found a 20 percent increase compared with 2012.<sup><xref rid="R3" ref-type="bibr">3</xref>
</sup>
Similar trends are reported in Europe<sup><xref rid="R4" ref-type="bibr">4</xref>
</sup>
and Asia.</p>
<p>Aesthetic use of botulinum toxin type A is supported by a broad literature base. Of the available formulations, onabotulinumtoxinA (Allergan, Inc., Irvine, Calif.) has the most approved clinical indications. It is the most widely studied formulation for cosmetic and therapeutic purposes, with more than 2800 clinical and nonclinical articles published between 1986 and 2013, and more than 400 peer-reviewed articles.<sup><xref rid="R5" ref-type="bibr">5</xref>
</sup>
The body of literature that addresses abobotulinumtoxinA (Galderma Laboratories, L.P., Fort Worth, Texas), incobotulinumtoxinA (Merz Pharmaceuticals, Raleigh, N.C.) and other formulations is also growing.</p>
<p>North American consensus recommendations for botulinum toxin type A were revised and updated in 2008.<sup><xref rid="R6" ref-type="bibr">6</xref>
</sup>
European (French) guidelines were published in 2011.<sup><xref rid="R7" ref-type="bibr">7</xref>
,<xref rid="R8" ref-type="bibr">8</xref>
</sup>
Comparative guidelines for onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA were provided by five experts from Canada, Europe, and South America in 2013.<sup><xref rid="R9" ref-type="bibr">9</xref>
</sup>
Treatment strategies have progressed rapidly, reflecting increasing patient diversity with respect to gender, age, and ethnicity, as well as the growing number of patients who receive repeated treatment over years or decades. Geographic variations have evolved as worldwide use has expanded. This is a manifestation of prevalent facial morphotypes and global migration patterns, and also of cultural differences in aesthetic ideals. The 2014 American Society for Aesthetic Plastic Surgery survey results exemplify these demographic trends, reporting that approximately 22 percent of all cosmetic procedures were performed on ethnic minorities, and approximately 11.5 percent of botulinum toxin procedures were performed on men.<sup><xref rid="R1" ref-type="bibr">1</xref>
</sup>
</p>
<sec><title>CONSENSUS OBJECTIVES AND METHODOLOGY</title>
<p>In January of 2014, a multinational group of key opinion leaders in plastic surgery, dermatology, facial plastic surgery, and oculoplastic surgery convened the Global Aesthetics Consensus Group. The objectives were to review aesthetic applications of botulinum toxin type A and hyaluronic acid fillers, and to provide updated consensus recommendations. The methodology used by the panel for determining consensus is summarized in Table <xref ref-type="table" rid="T1">1</xref>
. This publication presents the panel’s recommendations and position statements for botulinum toxin, based on integration of its clinical experience with published data. It includes new guidelines for treatment planning and implementation, and updates to previous guidelines for avoidance and management of complications from aesthetic use of botulinum toxin. Another publication in the Global Aesthetics Consensus Group series provides recommendations for combined treatment with botulinum toxin and hyaluronic acid fillers, and optimization of treatment outcomes in diverse patient populations.<sup><xref rid="R10" ref-type="bibr">10</xref>
</sup>
</p>
<table-wrap id="T1" position="float"><label>Table 1.</label>
<caption><p>Methodology for Global Aesthetics Consensus Group Panel Consensus</p>
</caption>
<graphic xlink:href="prs-137-518e-g002"></graphic>
</table-wrap>
</sec>
<sec><title>BOTULINUM TOXIN TYPE A: INDICATIONS AND PRACTICAL CONSIDERATIONS</title>
<p>Since 2009, the U.S. Food and Drug Administration has mandated nonproprietary names for botulinum toxin type A formulations that it approves for aesthetic or therapeutic use.<sup><xref rid="R11" ref-type="bibr">11</xref>
</sup>
This is to clarify that different formulations are chemically and pharmacologically unique, that their doses are not interchangeable, and that their dose-response curves are not parallel.<sup><xref rid="R11" ref-type="bibr">11</xref>
–<xref rid="R15" ref-type="bibr">15</xref>
</sup>
</p>
<p>OnabotulinumtoxinA has regulatory approval under brand names that include Botox Cosmetic, Vistabel, Vistabex, and Botox Vista. AbobotulinumtoxinA has approval under the brand names Dysport and Azzalure, and incobotulinumtoxinA has approval under the brand names Xeomin, Xeomeen, and Bocouture. The formulations are approved in numerous countries for treatment of glabellar lines. Additional indications in some countries include treatment of lateral canthal lines, facial hyperkinetic lines, and/or upper facial lines.<sup><xref rid="R5" ref-type="bibr">5</xref>
</sup>
Off-label use for other aesthetic indications is common.</p>
<p>Table <xref ref-type="table" rid="T2">2</xref>
summarizes Food and Drug Administration product labeling for reconstitution, storage, and administration of onabotulinumtoxinA, as well as off-label methods used by the panelists.<sup><xref rid="R12" ref-type="bibr">12</xref>
</sup>
A postapproval double-blind, randomized, controlled study demonstrated less procedural pain after reconstitution with benzoic acid-preserved (bacteriostatic) 0.9% saline.<sup><xref rid="R16" ref-type="bibr">16</xref>
</sup>
A recent expert consensus concluded unanimously that reconstituted botulinum toxin can be refrigerated or refrozen for at least 4 weeks before injection without significant risk for contamination or decreased effectiveness, and used to treat multiple patients, assuming there is appropriate handling.<sup><xref rid="R17" ref-type="bibr">17</xref>
</sup>
This affirms previous postapproval data<sup><xref rid="R18" ref-type="bibr">18</xref>
,<xref rid="R19" ref-type="bibr">19</xref>
</sup>
and a prospective simulation study of common, off-label reconstitution and storage methods (Table <xref ref-type="table" rid="T3">3</xref>
).<sup><xref rid="R20" ref-type="bibr">20</xref>
</sup>
Some panelists prefer higher reconstitution volumes and, hence, injection volumes per unit dose, when they desire greater toxin spread. Others feel that higher volumes are associated with more procedural pain and greater temporary postprocedural visibility of injection sites.</p>
<table-wrap id="T2" position="float"><label>Table 2.</label>
<caption><p>U.S. Food and Drug Administration Product Labeling for Reconstitution, Storage, and Administration of OnabotulinumtoxinA and Off-Label Methods Used by Consensus Panelists</p>
</caption>
<graphic xlink:href="prs-137-518e-g003"></graphic>
</table-wrap>
<table-wrap id="T3" position="float"><label>Table 3.</label>
<caption><p>Summary of Prospective Simulation Study of Sterility of Multiple-Use Botulinum Toxin Type A Vials*</p>
</caption>
<graphic xlink:href="prs-137-518e-g004"></graphic>
</table-wrap>
</sec>
<sec><title>EVOLVING PARADIGMS IN PATIENT ASSESSMENT AND TREATMENT PLANNING</title>
<sec><title>Panfacial, Diagnostic Approach</title>
<p>Although the face is discussed in horizontal one-thirds in this consensus document, the panel stressed the importance of an integrated, panfacial approach. The original paradigm with toxin and fillers was to relax the upper face, fill the midface, and relax and fill the lower face.<sup><xref rid="R6" ref-type="bibr">6</xref>
</sup>
Appropriate patient assessment and understanding of the etiology of what is observed catalyze an evolution toward more equal use of toxin and fillers in all facial zones. Muscles are targeted where their excessive contraction is the primary cause of the changes that are seen. Volume is restored where this is the primary cause.</p>
<p>Full assessment for botulinum toxin treatment includes anatomical and functional analysis of the musculature in the context of facial morphology and the qualitative and quantitative status of hard and soft tissues. Full understanding of the relationships between muscles is required. Skin snap and stretch tests are valuable for revealing soft-tissue quality and the etiology of rhytides. When determining whether botulinum toxin is appropriate, the risk of impaired function must be considered. This diagnostic approach allows selection of the safest and most effective treatment option with modification for repeated treatments, older patients, and the emerging indication of early, proactive, or even preventive treatment of younger patients. Treatment planning in these situations is discussed in the Global Aesthetics Consensus Group publication on combined treatments and optimization of outcomes in diverse patient populations.<sup><xref rid="R10" ref-type="bibr">10</xref>
</sup>
</p>
</sec>
<sec><title>Patient-Tailored Approach</title>
<p>It is crucial to establish good physician-patient rapport, assess patients’ objectives<sup><xref rid="R21" ref-type="bibr">21</xref>
,<xref rid="R22" ref-type="bibr">22</xref>
</sup>
in the context of what is seen on examination, and provide patient education. Verbal education can be supplemented by written handouts, visual aids, audiovisual media, and content from Internet websites.</p>
<p>Although the original objective of botulinum toxin treatment was to paralyze target muscles, current understanding is that the most desirable outcome is modulation of muscular activity. The consensus panel noted trends in daily practice toward decreased dosages and increased injection intervals. This is supported by a recent retrospective medical chart review of 194 patients who received onabotulinumtoxinA to treat glabellar lines during a mean of 9.1 years.<sup><xref rid="R23" ref-type="bibr">23</xref>
</sup>
Separate analysis of the same data set demonstrated sustained patient and physician satisfaction with repeated treatment.<sup><xref rid="R24" ref-type="bibr">24</xref>
</sup>
Patients reported greater reduction in their perceived age as they received treatments for longer periods.<sup><xref rid="R23" ref-type="bibr">23</xref>
</sup>
</p>
<p>While it is useful to recognize the influence of demographic characteristics such as gender or ethnicity on rhytide patterns,<sup><xref rid="R25" ref-type="bibr">25</xref>
–<xref rid="R29" ref-type="bibr">29</xref>
</sup>
the key to successful treatment is individualized patient assessment. Cultural expectations are not synonymous with ethnic origin, and patients may have specific preferences regarding the magnitude and nature of results. Validated wrinkle classification and rating scales<sup><xref rid="R30" ref-type="bibr">30</xref>
,<xref rid="R31" ref-type="bibr">31</xref>
</sup>
and software programs that depict age-related changes<sup><xref rid="R32" ref-type="bibr">32</xref>
</sup>
can be of value in communicating expected outcomes to patients.</p>
<p>Comprehensive facial assessment encompasses both static and dynamic observation. The real image of a patient, and thus, the most accurate pretreatment evaluation, is obtained through observation of spontaneous animation rather than animation on command. Therefore, assessment begins before formal examination, during history-taking and while the physician and patient are in dialogue. In a panfacial context, individual muscle mass, anatomy, and contraction pattern can guide appropriate toxin dosing and placement.<sup><xref rid="R33" ref-type="bibr">33</xref>
–<xref rid="R36" ref-type="bibr">36</xref>
</sup>
It is helpful to use validated grading scales for muscle mass<sup><xref rid="R33" ref-type="bibr">33</xref>
</sup>
and to palpate muscles while visualizing them.<sup><xref rid="R33" ref-type="bibr">33</xref>
</sup>
</p>
</sec>
<sec><title>Approach to Multiple Areas</title>
<p>The indications for treating a facial area are the same, whether single or multiple areas are to be addressed. Aging occurs as a continuum across areas. The panel observed that treatment of two adjacent areas can produce the same or potentially better results with reduced dosage per injection point. Conversely, overcorrection of one area may cause local improvement, but it will usually cause detriment to the surroundings, through unnatural appearance and/or recruitment of other muscles that were previously less active.</p>
<p>Given the trend toward lower dosing, clinicians should be mindful of the balance between efficacy and aesthetic outcome. The quality of results should not be subordinated to their longevity. Repeated, high dosing of some muscles may cause atrophy and, hence, volume loss. The possibility of compensatory hypertrophy in nontarget muscles should also be considered (e.g., hypertrophy of temporalis and/or pterygoid muscles when targeting the masseter).</p>
<p>Prospective, randomized, placebo-controlled studies show that treatment of multiple upper facial lines with onabotulinumtoxinA significantly improves patient-reported outcomes. One study involved 40 subjects.<sup><xref rid="R37" ref-type="bibr">37</xref>
</sup>
Another, which involved 917 subjects, investigated treatment of lateral canthal lines alone (12 units per side) or together with glabellar lines (20 units).<sup><xref rid="R38" ref-type="bibr">38</xref>
</sup>
Investigator and patient assessments revealed greater benefit when lateral canthal and glabellar lines were treated simultaneously. An additional trial of 445 subjects evaluated onabotulinumtoxinA in treatment of lateral canthal lines alone and led to approval by the European Union and U.S. Food and Drug Administration for this indication.<sup><xref rid="R39" ref-type="bibr">39</xref>
</sup>
</p>
</sec>
<sec sec-type="subjects"><title>Younger and Older Patients</title>
<p>A comprehensive review of emerging concepts in facial aging and how patient age impacts treatment is provided in the Global Aesthetics Consensus Group publication on combined treatments and optimization of outcomes in diverse patient populations.<sup><xref rid="R10" ref-type="bibr">10</xref>
</sup>
The objective to prevent rhytides is most applicable to younger patients. Loss of volume and consequent deflation of the soft tissues and underlying, supportive bone are cardinal features of facial aging.<sup><xref rid="R40" ref-type="bibr">40</xref>
–<xref rid="R46" ref-type="bibr">46</xref>
</sup>
The majority of the consensus panel considered it critical to development of age-appropriate treatment goals to understand that these changes may impact muscular activity as well as facial contours. A greater proportion of rhytides in older patients may be due to loss of skin elasticity. They can be ameliorated by multiple modalities, including botulinum toxin, but probably not toxin alone. Lower doses may be appropriate, due to changes in muscle mass and function with age.</p>
</sec>
</sec>
<sec><title>CONSENSUS RECOMMENDATIONS</title>
<p>Consensus recommendations for onabotulinumtoxinA injection sites and dosages are provided in Tables <xref ref-type="table" rid="T4">4</xref>
through <xref ref-type="table" rid="T6">6</xref>
. Table <xref ref-type="table" rid="T7">7</xref>
provides general Global Aesthetics Consensus Group recommendations and position statements. The recommendations may be extrapolated with care, and appropriate dosages, to other botulinum toxin formulations.</p>
<table-wrap id="T4" position="float"><label>Table 4.</label>
<caption><p>Consensus Recommendations and Expert Panel Opinions Regarding OnabotulinumtoxinA Treatment of the Upper Face</p>
</caption>
<graphic xlink:href="prs-137-518e-g005"></graphic>
</table-wrap>
<table-wrap id="T5" position="float"><label>Table 5.</label>
<caption><p>Consensus Recommendations and Expert Panel Opinions Regarding OnabotulinumtoxinA Treatment of the Midface</p>
</caption>
<graphic xlink:href="prs-137-518e-g006"></graphic>
</table-wrap>
<table-wrap id="T6" position="float"><label>Table 6.</label>
<caption><p>Consensus Recommendations and Expert Panel Opinions Regarding OnabotulinumtoxinA Treatment of the Lower Face</p>
</caption>
<graphic xlink:href="prs-137-518e-g007"></graphic>
</table-wrap>
<table-wrap id="T7" position="float"><label>Table 7.</label>
<caption><p>Global Aesthetics Consensus Group Recommendations and Position Statements for Botulinum Toxin Type A</p>
</caption>
<graphic xlink:href="prs-137-518e-g008"></graphic>
</table-wrap>
<sec><title>Upper Face: Glabellar, Lateral Canthal, and Horizontal Forehead Lines</title>
<p>Premeeting panel surveys indicated that botulinum toxin alone was the most common approach for the upper face (Fig. <xref ref-type="fig" rid="F1">1</xref>
). Growing evidence supports treatment of the glabella and lateral canthal lines, or of multiple areas including these regions.<sup><xref rid="R37" ref-type="bibr">37</xref>
–<xref rid="R39" ref-type="bibr">39</xref>
,<xref rid="R47" ref-type="bibr">47</xref>
–49</sup>
It was recognized that hyaluronic acid fillers also play an important role.</p>
<fig id="F1" position="float"><label>Fig. 1.</label>
<caption><p>Practice patterns of the consensus panel in the upper face (<italic>left</italic>
), midface (<italic>center</italic>
), and lower face (<italic>right</italic>
) based on premeeting surveys. Percentage use of botulinum toxin type A alone, filler alone, and botulinum toxin type A plus filler is shown for each facial zone. <italic>PO</italic>
, perioral; <italic>OC/ML</italic>
, oral commissure or marionette lines. <italic>Black</italic>
, botulinum toxin type A alone; <italic>white</italic>
, filler alone; <italic>gray</italic>
, botulinum toxin type A plus filler. *Percentages are rounded to the nearest whole number and may not total 100 because of rounding.</p>
</caption>
<graphic xlink:href="prs-137-518e-g009"></graphic>
</fig>
<p>Compared with previous guidelines, the Global Aesthetics Consensus Group recommended lower minimum doses and numbers of injection points (e.g., three to seven injection points for the glabella with total dosage of 12 to 40 units in most cases, and doses lower than 12 units when indicated). The publications cited above for glabellar lines pertain to treatment at maximal frown. Two randomized, double-blind, placebo-controlled studies of mild glabellar lines in repose demonstrated effective elimination with a 20-unit dose of onabotulinumtoxinA.<sup><xref rid="R50" ref-type="bibr">50</xref>
</sup>
A meta-analysis of four trials with 621 patients found that 20-unit treatment of glabellar lines resulted in sustained clinical benefit for 4 months in more than half of responders.<sup><xref rid="R51" ref-type="bibr">51</xref>
</sup>
Patient satisfaction increased with duration of effect.</p>
<p>For lateral canthal lines, some panelists suggested a reduction in dose per injection site for the inferior lateral orbicularis oculi and combined treatment with hyaluronic acid fillers to address lines that encroach inferiorly on the cheek. They recommended avoidance of the second row of injections that was described previously for rhytides that extend toward the temporal hairline, considering volume loss as their primary etiology and with the aim of avoiding complications. Other panelists advocated a second row of injections for patients whose skin is severely sun damaged or who have undergone cosmetic surgery, such as face lifting with consequent extension of rhytides as far as the hairline.</p>
<p>For horizontal forehead lines, some panelists use intracutaneous injection, especially near the eyebrow, to achieve superficial delivery of toxin to the underlying frontalis with lower dose per unit volume of muscle. The objective is to modulate the depth and magnitude of effect, thus improving rhytides without causing eyebrow descent.</p>
</sec>
<sec><title>Midface: Infraorbital Rhytides, Nasal Oblique Lines, Nasal Flare, Nasal Tip Elevation, and Excessive Gingival Show</title>
<p>Clinical data pertaining to botulinum toxin type A alone for the midface are limited.<sup><xref rid="R52" ref-type="bibr">52</xref>
–<xref rid="R54" ref-type="bibr">54</xref>
</sup>
The 2010 French consensus publication included multidisciplinary recommendations for prevention and treatment of rhytides in this region.<sup><xref rid="R7" ref-type="bibr">7</xref>
</sup>
In premeeting surveys, panelists reported using botulinum toxin alone for infraorbital rhytides in 49 percent of cases and in 42 percent of procedures for nasal lines, nasal flare, or nasal tip elevation (Fig. <xref ref-type="fig" rid="F1">1</xref>
). Filler alone was the treatment of choice for the cheek.</p>
<p>The panelists recognized the contribution of the nasalis muscle to nasal oblique lines, the current understanding that the levator labii superioris alaeque nasi often has a primary role, and that patterns of secondary muscle recruitment must be considered.<sup><xref rid="R29" ref-type="bibr">29</xref>
</sup>
Several panelists considered use of botulinum toxin for nasal tip elevation to be ancillary to that of hyaluronic acid fillers, based on an understanding of the need to correct volume loss. Excessive gingival show (gummy smile) can be attributed to skeletal, gingival, and/or muscular factors.<sup><xref rid="R54" ref-type="bibr">54</xref>
</sup>
When appropriate, botulinum toxin can effectively target overactive lip elevator muscles.</p>
</sec>
<sec><title>Lower Face and Neck: Depressor Anguli Oris, Mentalis, Masseter, Perioral Rhytides, and Platysmal Bands</title>
<p>Previous guidelines focused on the benefits of combining hyaluronic acid fillers and botulinum toxin type A for the lower face.<sup><xref rid="R6" ref-type="bibr">6</xref>
</sup>
Recent clinical trials demonstrated the efficacy and safety of combination therapy for lower facial rejuvenation, with better results than either modality alone.<sup><xref rid="R56" ref-type="bibr">56</xref>
,<xref rid="R57" ref-type="bibr">57</xref>
</sup>
Although there are limited data for treatment of the lower face and neck with botulinum toxin alone,<sup><xref rid="R58" ref-type="bibr">58</xref>
–<xref rid="R60" ref-type="bibr">60</xref>
</sup>
clinical use is well documented. On the basis of premeeting surveys, Figure <xref ref-type="fig" rid="F1">1</xref>
summarizes the panelists’ use of botulinum toxin alone, combined treatment with fillers, and fillers alone.</p>
<p>The panel recommended a range of injection sites, dosages per injection site, and total doses in treatment of the masseter, depending on the objective (e.g., reduction of hypertrophy as a result of bruxism versus facial tapering for aesthetic reasons). To determine the appropriateness of toxin treatment, clinicians were advised to distinguish true masseteric hypertrophy from parotid gland hypertrophy or masseteric prominence as a result of volume loss, and to identify pathology such as parotid swelling related to Sjögren syndrome or bulimia nervosa.<sup><xref rid="R61" ref-type="bibr">61</xref>
</sup>
</p>
<p>The Global Aesthetics Consensus Group recommendations for orbicularis oris and for platysmal bands represent lower dosing than originally described. A limited and carefully selected population of patients can benefit from treatment of platysma from the mandibular border to the corner of the mouth (Nefertiti neck lift) to weaken the depressor action of platysma and hence produce relative augmentation of elevator action. These patients typically have good retention of tissue quality and palpable platysmal muscle mass, especially posteriorly, with a band that obscures the mandibular border when platysma is contracted while the patient is seated.</p>
</sec>
</sec>
<sec><title>CONTRAINDICATIONS, AVOIDANCE OF COMPLICATIONS, AND POSTTREATMENT RECOMMENDATIONS</title>
<p>Based on clinical experience, retrospective reviews, and meta-analyses, botulinum toxin type A has excellent safety and tolerability profiles across a spectrum of aesthetic and therapeutic applications.<sup><xref rid="R62" ref-type="bibr">62</xref>
–<xref rid="R64" ref-type="bibr">64</xref>
</sup>
Table <xref ref-type="table" rid="T8">8</xref>
presents some potential adverse events from aesthetic use. Their incidence can be minimized through following the guidelines in this publication regarding appropriate selection of patients, injection strategies, and dosages. A recent systematic review of 31 randomized or open-label clinical studies of botulinum toxin type A in aesthetic treatments quantified the incidence of treatment-related blepharoptosis (2.5 percent), brow ptosis (3.1 percent), eye sensory disorders (3 percent), and lip asymmetries and imbalances of the lower face (6.9 percent).<sup><xref rid="R62" ref-type="bibr">62</xref>
</sup>
Treatment-related adverse events were considered secondary to “excessive action of the drug,” or “diffusion to nearby unwanted targets.” OnabotulinumtoxinA was used in 60.0 percent of these studies, abobotulinumtoxinA in 37.1 percent, and incobotulinumtoxin in 2.8 percent of cases. A retrospective review from 2008 to 2013 of an American Society of Plastic Surgeons–endorsed database reported that patients older than 65 years of age had significantly more cosmetic facial procedures performed than younger patients (62.9 percent versus 12 percent). The complication rate after all procedures in the older group (mean age, 69.1 years; 1.94 percent) was statistically insignificant compared with that in the younger group (mean age, 39.2 years; 1.84 percent). This was despite the greater presence of higher body mass index, incidence of diabetes mellitus, and other health risks in the older group.<sup><xref rid="R63" ref-type="bibr">63</xref>
</sup>
</p>
<table-wrap id="T8" position="float"><label>Table 8.</label>
<caption><p>Some Potential Adverse Events from Aesthetic Use of Botulinum Toxin Type A*</p>
</caption>
<graphic xlink:href="prs-137-518e-g010"></graphic>
</table-wrap>
<p>General strategies to prevent complications from botulinum toxin type A injection are well described in previous guidelines.<sup><xref rid="R6" ref-type="bibr">6</xref>
,<xref rid="R9" ref-type="bibr">9</xref>
</sup>
The consensus panel noted growing realization that injection of toxin or filler is a minor surgical procedure from the perspective of pretreatment preparation. No procedure that breaches the skin surface can ever be sterile. Removal of all makeup, scrupulous skin cleansing before, during, and after injection, and sterile injection technique (including avoidance of injection through bacteria-rich fields such as hair follicles) are recommended to minimize avoidable contamination. Although it is desirable for patients to avoid anticoagulants, nonsteroidal anti-inflammatory drugs, fish oil supplements, and other agents that could increase postprocedural ecchymosis, use of these products is not a contraindication to treatment. Brief application of cold packs or ice to the treatment area after injection can help to minimize swelling and bruising. The consensus panel found no evidence to support previous posttreatment recommendations regarding avoidance of pressure on injected areas, strenuous exercise, or air travel.</p>
</sec>
<sec><title>SUMMARY AND CONCLUSIONS</title>
<p>The Global Aesthetics Consensus Group recommendations for botulinum toxin type A treatment of the face and neck are based on the accumulation of clinical experience and study data. Key recommendations include:</p>
<list list-type="bullet"><list-item><p>An individualized, integrated approach to assessment and treatment planning.</p>
</list-item>
<list-item><p>Selection of botulinum toxin as a primary treatment only if the target muscle is the primary etiology of the facial disharmony to be addressed.</p>
</list-item>
<list-item><p>Analysis of target muscles in the context of adjacent muscles and associated soft and hard tissues.</p>
</list-item>
<list-item><p>Lower doses for the upper face and some regions of the lower face.</p>
</list-item>
<list-item><p>Intracutaneous injection, where indicated to limit depth and magnitude of effects.</p>
</list-item>
<list-item><p>More frequent combination of toxin with fillers for all facial regions, including the upper face.</p>
</list-item>
</list>
</sec>
<sec><title>ACKNOWLEDGMENTS</title>
<p>The authors express their deep appreciation to Daniel Cassuto, M.D., and Taro Kono, M.D., for their expert guidance and input during development of this article, and to John F. Kross, M.Sc., D.M.D., of Educational Awareness Solutions, for his editorial support.</p>
</sec>
<sec><title>APPENDIX: GLOBAL AESTHETICS CONSENSUS GROUP</title>
<p>The Global Aesthetics Consensus Group comprises the following faculty members: André Vieira Braz, M.D., dermatology, Rio de Janeiro, Brazil; Jean D. A. Carruthers, M.D., F.R.C.S.(C), F.R.C.Ophth., ophthalmology, Vancouver, British Columbia, Canada; Koenraad L. De Boulle, M.D., dermatology, Aalst, Belgium; Steven Fagien, M.D., F.A.C.S., ophthalmic plastic surgery, Boca Raton, Fla.; Greg J. Goodman, M.D., F.A.C.D., dermatology, Carlton, Victoria, Australia; Soo-Keun Lee, M.D., Ph.D., dermatology, Seoul, Korea; Steven Liew, M.B.B.S., F.R.A.C.S., plastic surgery, Sydney, New South Wales, Australia; Gary Monheit, M.D., F.A.A.D., dermatology, Birmingham, Ala.; Hervé Raspaldo, M.D., facial plastic surgery, Cannes, France; Rod Rohrich, M.D., F.A.C.S., plastic surgery, Dallas, Texas; Gerhard Sattler, M.D., dermatology, Darmstadt, Germany; Massimo Signorini, M.D., plastic surgery, Milan, Italy; Hema Sundaram, M.D., F.A.A.D., dermatology, Rockville, Md.; Arthur Swift, M.D., C.M., F.R.C.S.(C), plastic surgery, Montreal, Quebec, Canada; Ada R. Trindade de Almeida, M.D., dermatology, Sao Paolo, Brazil; and Yan Wu, M.D., Ph.D., dermatology, Beijing, China.</p>
</sec>
</body>
<back><fn-group><fn fn-type="other"><p>The faculty of the Global Aesthetics Consensus Group is listed in the Appendix.</p>
</fn>
<fn fn-type="financial-disclosure"><p><bold>Disclosure:</bold>
<italic>The consensus meeting and editorial assistance for manuscript development were organized by Educational Awareness Solutions of Norwalk, Conn., and supported by Allergan, Inc., Irvine, Calif. André Vieira Braz, M.D., states that he is a consultant and speaker with Allergan, Galderma, and Palomar. Jean D. A. Carruthers, M.D., states that she is a consultant and researcher with Allergan, Merz, and Kythera. Daniel Cassuto, M.D., states that he has no relevant disclosures. Koenraad L. De Boulle, M.D., states that he is a consultant, member of the speaker’s board, and recipient of honoraria and grants for studies and lectures for Allergan; a consultant for Kythera and Genévrier; and a consultant and member of the speaker’s bureau for Johnson & Johnson. Steven Fagien, M.D., states that he is a consultant/investigator for Allergan, Galderma, Merz, Kythera, and Aquavit. Greg J. Goodman, M.D., states that he has no financial interests that would conflict with the article; he serves on advisory boards and speaker panels for Allergan, Galderma, and Merz that may be seen to have an interest in the outcome of a consensus document. Taro Kono, M.D., states that he has no relevant disclosures. Soo-Keun Lee, M.D., states that he is a consultant for Allergan. Steven Liew, M.B.B.S., states that he serves on advisory boards for Allergan, Galderma, and Kythera and has received honoraria from Allergan and Galderma for delivering local and international workshops, lectures, and trials. Gary Monheit, M.D., states that he is a consultant and clinical investigator for Allergan Corporation (Juvéderm), Ipsen/Medicis (Dysport), MELA Sciences, Inc. (MelaFind), Revance, Kythera, Galderma, Mentor, and Merz; a consultant for Myoscience and Qmed; and a clinical investigator for Dermik Laboratories (Sculptra) and Contura (Aquamid). Hervé Raspaldo, M.D., states that he is a consultant for Allergan. Rod Rohrich, M.D., states that he is an expert for Allergan Medical and receives book royalties from Quality Medical Publishing and Taylor and Francis Publishing and instrument royalties from Eriem Surgical, Inc. Gerhard Sattler, M.D., states that he is a clinical investigator for Allergan, Galderma, Merz, Regeneron, and Novartis; a participant in advisory board meetings for Allergan, Galderma, and Merz; and a speaker for Allergan, Galderma, and Merz. Massimo Signorini, M.D., states that he is a medical expert for and takes part in advisory boards and workshops for Allergan, Inc. Hema Sundaram, M.D., states that she serves as a clinical investigator and/or consultant for Allergan, CosmoFrance, Evolus/Strathspey Crown, Galderma, HaoHai Healthcare, Institut Biochimique SA, Kythera, Merz, and Teoxane. Arthur Swift, M.D., states that he is a speaker, clinical researcher and advisor to Allergan, Galderma, and Merz. Ada R. Trindade de Almeida, M.D., states that she is an advisor for Allergan, Merz, Galderma, Roc, and Mantecorp, has participated in clinical trials for Allergan, and is a speaker for Allergan and Theraskin. Yan Wu, M.D., states that she serves as a consultant and/or clinical investigator for Allergan, GlaxoSmithKline, Lanzhou Biological Products Institute, and Freda Biopharm (Shandong hyaluronic acid filler</italic>
).</p>
</fn>
</fn-group>
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