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

Hema Sundaram, Massimo Signorini, Steven Liew, Ada R Trindade de Almeida, Yan Wu, André Vieira Braz, Steven Fagien, Greg J Goodman, Gary Monheit, Hervé Raspaldo, Global Aesthetics Consensus Group, Hema Sundaram, Massimo Signorini, Steven Liew, Ada R Trindade de Almeida, Yan Wu, André Vieira Braz, Steven Fagien, Greg J Goodman, Gary Monheit, Hervé Raspaldo, Global Aesthetics Consensus Group

Abstract

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.

Figures

Fig. 1.
Fig. 1.
Practice patterns of the consensus panel in the upper face (left), midface (center), and lower face (right) 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. PO, perioral; OC/ML, oral commissure or marionette lines. Black, botulinum toxin type A alone; white, filler alone; gray, botulinum toxin type A plus filler. *Percentages are rounded to the nearest whole number and may not total 100 because of rounding.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5242214/bin/prs-137-518e-g001.jpg

References

    1. American Society for Aesthetic Plastic Surgery (ASAPS) Cosmetic surgery national data bank statistics. 2014. Available at: . Accessed June 21, 2015.
    1. International Society of Aesthetic Plastic Surgery (ISAPS). International survey on aesthetic/cosmetic procedures performed in 2014. Available at: . Accessed July 13, 2015.
    1. American Society for Dermatologic Surgery (ASDS) ASDS survey: Skin cancer, cosmetic procedures jump 22 percent in 2013. 2013 ASDS survey on dermatologic procedures. Available at: . Accessed December 24, 2014.
    1. Associazione Italiana Chirurgia Plastica Estetica (AICPE) Comunicati Stampa: Bellezza, i dati AICPE: Quasi un milione i trattamenti di medicina e chirurgia estetica eseguiti nel 2013. Available at: . Accessed March 6, 2015.
    1. Mohindru A, Bulloch S, Kronfeld N, et al. Analysis of clinical and non-clinical, peer-reviewed published studies investigating the use of commercially available botulinum toxins: An online literature review. Poster presented at: Second International Congress on Treatment of Dystonia (ITCD); May 8–11, 2013; Hannover, Germany.
    1. Carruthers JD, Glogau RG, Blitzer A Facial Aesthetics Consensus Group Faculty. Advances in facial rejuvenation: botulinum toxin type a, hyaluronic acid dermal fillers, and combination therapies–consensus recommendations. Plast Reconstr Surg. 2008;121(5 Suppl):5S–30S; quiz 31S.
    1. Raspaldo H, Baspeyras M, Bellity P, et al. Consensus Group. Upper- and mid-face anti-aging treatment and prevention using onabotulinumtoxin A: The 2010 multidisciplinary French consensus–part 1. J Cosmet Dermatol. 2011;10:36–50.
    1. Raspaldo H, Niforos FR, Gassia V, et al. Consensus Group. Lower-face and neck antiaging treatment and prevention using onabotulinumtoxin A: The 2010 multidisciplinary French consensus–part 2. J Cosmet Dermatol. 2011;10:131–149.
    1. Carruthers J, Fournier N, Kerscher M, Ruiz-Avila J, Trindade de Almeida AR, Kaeuper G. The convergence of medicine and neurotoxins: A focus on botulinum toxin type A and its application in aesthetic medicine–a global, evidence-based botulinum toxin consensus education initiative: part II: Incorporating botulinum toxin into aesthetic clinical practice. Dermatol Surg. 2013;39:510–525.
    1. Sundaram H, Liew S, Signorini M, et al. Global Aesthetics Consensus Group: Hyaluronic acid fillers and botulinum toxin type A: Recommendations for combined treatment and special considerations to optimize outcomes in diverse patient populations. Plast Reconstr Surg
    1. U.S. Food and Drug Administration. Alert (08/2009): Information for healthcare professionals: Onabotulinumtoxina (marketed as onabotulinumtoxin a/onabotulinumtoxin a cosmetic), abobotulinumtoxina (marketed as dysport), and rimabotulinumtoxinb (marketed as myobloc). Available at: . Accessed March 5, 2014.
    1. Irvine, Calif: Allergan, Inc.; 2013.
    1. Scottsdale, Ariz.: Medicis Pharmaceutical Corp.; 2012.
    1. Greensboro, N.C.: Merz Pharmaceuticals, LLC; 2014.
    1. Chen JJ, Dashtipour K. Abo-, inco-, ona-, and rima-botulinum toxins in clinical therapy: A primer. Pharmacotherapy. 2013;33:304–318.
    1. Alam M, Dover JS, Arndt KA. Pain associated with injection of botulinum A exotoxin reconstituted using isotonic sodium chloride with and without preservative: A double-blind, randomized controlled trial. Arch Dermatol. 2002;138:510–514.
    1. Alam M, Bolotin D, Carruthers J, et al. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015;41:321–326.
    1. Hexsel DM, De Almeida AT, Rutowitsch M, et al. Multicenter, double-blind study of the efficacy of injections with botulinum toxin type A reconstituted up to six consecutive weeks before application. Dermatol Surg. 2003;29:523–529.
    1. Trindade De Almeida AR, Secco LC, Carruthers A. Handling botulinum toxins: An updated literature review. Dermatol Surg. 2011;37:1553–1565.
    1. Alam M, Yoo SS, Wrone DA, White LE, Kim JY. Sterility assessment of multiple use botulinum A exotoxin vials: A prospective simulation. J Am Acad Dermatol. 2006;55:272–275.
    1. Nguyen TV, Hong J, Prose NS. Compassionate care: Enhancing physician-patient communication and education in dermatology: Part I. Patient-centered communication. J Am Acad Dermatol. 2013;68:353.e1–353.e8.
    1. Hong J, Nguyen TV, Prose NS. Compassionate care: Enhancing physician-patient communication and education in dermatology: Part II. Patient education. J Am Acad Dermatol. 2013;68:364.e1–364.e10.
    1. Carruthers A, Gallagher C, Darmody S. Evolution of facial aesthetic treatment over 5 or more years: An international, retrospective, cross-sectional analysis of continuous onabotulinumtoxin A treatment. J Am Acad Dermatol. 2014;70:AB17.
    1. Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: A retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015;41:S19–S28.
    1. Kane MA. Classification of crow’s feet patterns among Caucasian women: The key to individualizing treatment. Plast Reconstr Surg. 2003;112(5 Suppl):33S–39S.
    1. Kane MA, Cox SE, Jones D, Lei X, Gallagher CJ. Heterogeneity of crow’s feet line patterns in clinical trial subjects. Dermatol Surg. 2015;41:447–456.
    1. Lam SM. Aesthetic strategies for the aging Asian face. Facial Plast Surg Clin North Am. 2007;15:283–291.
    1. Park DH, Han DG, Shim JS, et al. Analysis of the patterns of lateral canthal rhytids and reference for botulinum toxin treatment in Orientals. Aesthetic Plast Surg. 2012;36:1211–1215.
    1. Tamura BM, Odo MY, Chang B, Cucé LC, Flynn TC. Treatment of nasal wrinkles with botulinum toxin. Dermatol Surg. 2005;31:271–275.
    1. Shoshani D, Markovitz E, Monstrey SJ, Narins DJ. The modified Fitzpatrick wrinkle scale: A clinical validated measurement tool for nasolabial wrinkle severity assessment. Dermatol Surg. 2008;34(Suppl 1):S85–S91. discussion S91.
    1. Carruthers A, Carruthers J, Hardas B, et al. A validated grading scale for crow’s feet. Dermatol Surg. 2008;34(Suppl 2):S173–S178.
    1. Goodman GJ, Halstead MB, Rogers JD, et al. A software program designed to educate patients on age-related skin changes of facial and exposed extrafacial regions: The results of a validation study. Clin Cosmet Investig Dermatol. 2012;5:23–31.
    1. Monheit G, Lin X, Nelson D, Kane M. Consideration of muscle mass in glabellar line treatment with botulinum toxin type A. J Drugs Dermatol. 2012;11:1041–1045.
    1. Braz AV, Sakuma TH. Patterns of contraction of the frontalis muscle: A pilot study. Surg Cosmet Dermatol. 2010;2:191–194.
    1. Benedetto AV, Lahti JG. Measurement of the anatomic position of the corrugator supercilii. Dermatol Surg. 2005;31:923–927.
    1. de Almeida AR, da Costa Marques ER, Banegas R, Kadunc BV. Glabellar contraction patterns: A tool to optimize botulinum toxin treatment. Dermatol Surg. 2012;38:1506–1515.
    1. Carruthers J, Carruthers A. Botulinum toxin type A treatment of multiple upper facial sites: Patient-reported outcomes. Dermatol Surg. 2007;33:S10–S17.
    1. Moers-Carpi M, Carruthers J, Fagien S, et al. Efficacy and safety of onabotulinumtoxinA for treating crow’s feet lines alone or in combination with glabellar lines: A multicenter, randomized, controlled trial. Dermatol Surg. 2015;41:102–112.
    1. Carruthers A, Bruce S, de Coninck A, et al. Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: A multicenter, randomized, controlled trial. Dermatol Surg. 2014;40:1181–1190.
    1. Coleman SR, Grover R. The anatomy of the aging face: Volume loss and changes in 3-dimensional topography. Aesthet Surg J. 2006;26(1S):S4–S9.
    1. Mendelson B, Wong CH. Changes in the facial skeleton with aging: Implications and clinical applications in facial rejuvenation. Aesthetic Plast Surg. 2012;36:753–760.
    1. Shaw RB, Jr, Katzel EB, Koltz PF, Kahn DM, Girotto JA, Langstein HN. Aging of the mandible and its aesthetic implications. Plast Reconstr Surg. 2010;125:332–342.
    1. Lambros V. Models of facial aging and implications for treatment. Clin Plast Surg. 2008;35:319–27. discussion 317.
    1. Lambros V. Observations on periorbital and midface aging. Plast Reconstr Surg. 2007;120:1367–76. discussion 1377.
    1. Pessa JE, Zadoo VP, Yuan C, et al. Concertina effect and facial aging: Nonlinear aspects of youthfulness and skeletal remodeling, and why, perhaps, infants have jowls. Plast Reconstr Surg. 1999;103:635–644.
    1. Albert AM, Ricanek K, Jr., Patterson E. A review of the literature on the aging adult skull and face: Implications for forensic science research and applications. Forensic Sci Int. 2007;172:1–9.
    1. Michaels BM, Csank GA, Ryb GE, Eko FN, Rubin A. Prospective randomized comparison of onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport) in the treatment of forehead, glabellar, and periorbital wrinkles. Aesthet Surg J. 2012;32:96–102.
    1. Kassir R, Kolluru A, Kassir M. Triple-blind, prospective, internally controlled comparative study between abobotulinumtoxina and onabotulinumtoxina for the treatment of facial rhytids. Dermatol Ther (Heidelb) 2013;3:179–189.
    1. Fabi SG, Sundaram H, Guiha I, Goldman MP. A two-center, open-label, randomized, split-face study to assess the efficacy and safety of one versus three intradermal injection sites of abobotulinumtoxinA in the treatment of lateral periocular rhytides. J Drugs Dermatol. 2013;12:932–937.
    1. Carruthers A, Carruthers J, Lei X, Pogoda JM, Eadie N, Brin MF. OnabotulinumtoxinA treatment of mild glabellar lines in repose. Dermatol Surg. 2010;36(Suppl 4):2168–2171.
    1. Glogau R, Kane M, Beddingfield F, et al. OnabotulinumtoxinA: A meta-analysis of duration of effect in the treatment of glabellar lines. Dermatol Surg. 2012;38:1794–1803.
    1. Flynn TC, Carruthers JA, Carruthers JA, Clark RE., II Botulinum A toxin (Botox) in the lower eyelid: Dose-finding study. Dermatol Surg. 2003;29:943–950. discussion 950.
    1. Flynn TC, Carruthers JA, Carruthers JA. Botulinum-A toxin treatment of the lower eyelid improves infraorbital rhytides and widens the eye. Dermatol Surg. 2001;27:703–708.
    1. Polo M. Botulinum toxin type A (Botox) for the neuromuscular correction of excessive gingival display on smiling (gummy smile). Am J Orthod Dentofacial Orthop. 2008;133:195–203.
    1. Hwang WS, Hur MS, Hu KS, et al. Surface anatomy of the lip elevator muscles for the treatment of gummy smile using botulinum toxin. Angle Orthod. 2009;79:70–77.
    1. Carruthers A, Carruthers J, Monheit GD, Davis PG, Tardie G. Multicenter, randomized, parallel-group study of the safety and effectiveness of onabotulinumtoxinA and hyaluronic acid dermal fillers (24-mg/ml smooth, cohesive gel) alone and in combination for lower facial rejuvenation. Dermatol Surg. 2010;36(Suppl 4):2121–2134.
    1. Custis T, Beynet D, Carranza D, Greco J, Lask GP, Kim J. Comparison of treatment of melomental fold rhytides with cross-linked hyaluronic acid combined with onabotulinumtoxinA and cross-linked hyaluronic acid alone. Dermatol Surg. 2010;36(Suppl 3):1852–1858.
    1. Lee SH, Wee SH, Kim HJ, et al. Abobotulinum toxin A and onabotulinum toxin A for masseteric hypertrophy: A split-face study in 25 Korean patients. J Dermatolog Treat. 2013;24:133–136.
    1. Cohen JL, Dayan SH, Cox SE, Yalamanchili R, Tardie G. OnabotulinumtoxinA dose-ranging study for hyperdynamic perioral lines. Dermatol Surg. 2012;38:1497–1505.
    1. Prager W, Bee EK, Havermann I, et al. IncobotulinumtoxinA for the treatment of platysmal bands. Dermatol Surg. 2015;41(Suppl 1):588–592.
    1. Goodman GJ. The masseters and their treatment with botulinum toxin (Botox). In: Carruthers A, Carruthers J, editors. Botulinum Toxin (Botox) 3rd ed. Philadelphia, Pa.: Saunders; 2013.
    1. Brin MF, Boodhoo TI, Pogoda JM, et al. Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: A meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Acad Dermatol. 2009;61:961.e1–970.e1.
    1. Naumann M, Jankovic J. Safety of botulinum toxin type A: A systematic review and meta-analysis. Curr Med Res Opin. 2004;20:981–990.
    1. Cavallini M, Cirillo P, Fundarò SP, et al. Safety of botulinum toxin A in aesthetic treatments: A systematic review of clinical studies. Dermatol Surg. 2014;40:525–536.
    1. Yezhelyev M. Safety of cosmetic procedures in elderly and octogenarian patients. Poster presented at: American Society of Plastic Surgeons 2014 Annual Meeting; Chicago, Ill.; October 10–14, 2014.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa