Americian Society for Aesthetic Plastic Surgery 1997-2010 Cosmetic Surgery National Data Bank Statistics. Available at: www.surgery.org Accessed April 27, 2011.
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Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; for Botox Glabellar Lines II Study Group. Double-blind, placebo- controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003;112:1089-1098. Abstract
Carruthers A, Carruthers J, Lowe NJ, et al; for BOTOX Glabellar Lines I & II Study Groups. One-year, randomized, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res. 2004;7:1-20.
BOTOX Cosmetic [package insert]. Irvine, Calif: Allergan, Inc; 2009.
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Brandt F, Swanson N, Baumann L, Huber B. Randomized, placebo-controlled study of a new botulinum toxin type a for treatment of glabellar lines: efficacy and safety. Dermatol Surg. 2009;35:1893-1901. Abstract
Rubin M, Dover J, Glogau R, Goldberg D, Goldman M, Schlessinger J. The efficacy and safety of a new US botulinum toxin type A in the retreatment of glabellar lines following open-label treatment. J Drugs Dermatol. 2009;8:439-444. Abstract
Kane MA, Brandt F, Rohrich RJ, et al. Evaluation of variable-dose treatment with a new US botulinum toxin type a (Dysport) for correction of moderate to severe glabellar lines: results from a phase III, randomized, double-blind, placebo-controlled study. Plast Reconstr Surg. 2009;124:1619-1629. Abstract
Cohen JL, Schlessinger J, Cox SE, Lin X; Reloxin Investigational Group. An analysis of the long-term safety data of repeat administrations of botulinum neurotoxin type A-ABO for the treatment of glabellar lines. Aesthet Surg J. 2009;29(6 Suppl):S43-S49.
Moy R, Maas C, Monheit G, et al; for the Reloxin Investigational Group. Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines. Arch Facial Plast Surg. 2009;11:77-83. Abstract
DYSPORT [package insert]. Scottsdale, Ariz: Medicis Aesthetics Inc; 2010.
Brandt F, O'Connell C, Cazzaniga A, Waugh JM. Efficacy and safety evaluation of a novel botulinum toxin topical gel for the treatment of moderate to severe lateral canthal lines. Dermatol Surg. 2010;36(suppl 4):2111-2118. Abstract
Glogau RG. Topically applied botulinum toxin type A for the treatment of primary axillary hyperhidrosis: results of a randomized, blinded, vehicle-controlled study. Dermatol Surg. 2007;33(suppl 1):S76-S80.
Carruthers J, Carruthers A. Practical cosmetic Botox techniques. J Cutan Med Surg. 1999;3(4 suppl):S49-S52.
FDA requires boxed warning for all botulinum toxin products [news release]. US Food and Drug Administration; April 30, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm Accessed April 10, 2010.
FDA gives update on botulinum toxin safety warnings; established names of drugs changed [news release]. US Food and Drug Administration; August 3, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm Accessed April 10, 2010.
Borodic G. Botulinum toxin, immunologic considerations with long-term repeated use, with emphasis on cosmetic applications. Facial Plast Surg Clin North Am. 2007;15:11-16. Abstract
Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology. 2003;60:1186-1188. Abstract
Lawrence I, Moy R. An evaluation of neutralizing antibody induction during treatment of glabellar lines with a new US formulation of botulinum neurotoxin type A. Aesthet Surg J. 2009;29(6 Suppl):S66-S71.
Hanna PA, Jankovic J, Vincent A. Comparison of mouse bioassay and immunoprecipitation assay for botulinum toxin antibodies. J Neurol Neurosurg Psychiatry. 1999;66:612-616. Abstract
Brin MF, Comella CL, Jankovic J, Lai F, Maumann M; for the CD-017 BoNTA Study Group. Long-term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay. Mov Disord. 2008;23:1353-1360. Abstract
Naumann M, Carruthers A, Carruthers J, et al. Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications. Mov Disord. 2010;25:2211-2218. Abstract
Aoki KR. Pharmacology and immunology of botulinum neurotoxins. Int Ophthalmol Clin. 2005;45:25-37.
Atassi MZ. Basic immunological aspects of botulinum toxin therapy. Mov Disord. 2004;19 Suppl 8:S68-S84. Abstract
Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004;75:951-957. Abstract
Dressler D. Subclinical myasthenia gravis causing increased sensitivity to botulinum toxin therapy. J Neural Transm. 2010;117:1293-1294. Abstract
Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005;53:407-415. Abstract
Li M, Goldberger BA, Hopkins C. Fatal case of BOTOX-related anaphylaxis? J Forensic Sci. 2005;50:169-172.
Hexsel D, Spencer JM, Woolery-Lloyd H, Gilbert E. Practical applications of a new botulinum toxin. J Drugs Dermatol. 2010;9 (Suppl 3):31-37.
Borodic G. Myasthenic crisis after botulinum toxin. Lancet. 1998;352:1832.
Erbguth F, Claus D, Engelhardt A, Dressler D. Systemic effect of local botulinum toxin injections unmasks subclinical Lambert-Eaton myasthenic syndrome. J Neurol Neurosurg Psychiatry.1993;56:1235-1236. Abstract
Iwase T, Iwase C. Systemic effect of local and small-dose botulinum toxin injection to unmask subclinical myasthenia gravis. Graefes Arch Clin Exp Ophthalmol. 2006;244:415-416. Abstract
MacDonald MR, Spiegel JH, Raven RB, Kabaker SS, Maas CS. An anatomical approach to glabellar rhytids. Arch Otolaryngol Head Neck Surg. 1998;124:1315-1320. Abstract
Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin A in facial aesthetics. Plast Reconstr Surg. 2004;114(6 Suppl):1S-22S.
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. Abstract
Kane M, Donofrio L, Ascher B, et al. Expanding the use of neurotoxins in facial aesthetics: a consensus panel's assessment and recommendations. J Drugs Dermatol. 2010;9(Suppl 1):7-22.
Hsu TS, Dover JS, Arndt KA. Effect of volume and concentration on the diffusion of botulinum exotoxin A. Arch Dermatol. 2004;140:1351-1354. Abstract
Carruthers A, Carruthers J, Cohen J. Dilution volume of botulinum toxin type A for the treatment of glabellar rhytides: does it matter? Dermatol Surg. 2007;33(1 Spec No.):S97-S104.
Carruthers A, Cohen JL, Cox SE, et al. Facial aesthetics: achieving the natural, relaxed look. J Cosmet Laser Ther. 2007;9 Suppl 1:6-10. Abstract
Panjwani N, O'Keefe R, Pickett A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J. 2008;1:153-166.
Alam M, Yoo SS, Wrone DA, et al. Sterility assessment of multiple use botulinum A exotoxin vials: a prospective simulation. J Am Acad Dermatol. 2006;55:272-275. Abstract
Matarasso A, Shafer D. Botulinum neurotoxin type A-ABO (Dysport): clinical indications and practice guide. Aesthet Surg J. 2009;29(6 Suppl);S72-S79.
Ascher B, Zakine B, Kestemont P, et al. A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin a in the treatment of glabellar lines. J Am Acad Dermatol. 2004;51:223-233. Abstract
Carruthers A, Carruthers J, Cohen J. A prospective, double-blind, randomized, parellel-group, dose-ranging study of botulinum toxin type A in female subjects with horizontal forehead rhytides. Dermatol Surg. 2003;29:461-467. Abstract
Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005;31:414-422. Abstract
Carruthers A, Carruthers J. Prospective, double-blind, randomized, parallel-group, dose-ranging study of botulinum toxin type A in men with glabellar rhytids. Dermatol Surg. 2005;31:1297-1303. Abstract
Lowe NJ, Ascher B, Heckmann M, et al. Double-blind, randomized, placebo-controlled, dose-response study of the safety and efficacy of botulinum toxin type A in subjects with crow's feet. Dermatol Surg. 2005;31:257-262. Abstract
Rzany B, Dill-Muller D, Grablowitz D, et al; for the German-Austrian Retrospective Study Group. Repeated botulinum toxin A injections for the treatment of lines in the upper face: a retrospective study of 4,103 treatments in 945 patients. Dermatol Surg. 2007;33:S18-S25. Abstract
Carruthers J, Carruthers A. Complications of botulinum toxin type A. Facial Plast Surg Clin North Am. 2007;15:51-54,vi. Abstract
Alam M, Arndt KA, Dover JS. Severe, intractable headache after injection with botulinum a exotoxin: report of 5 cases. J Am Acad Dermatol. 2002;46:62-65. Abstract
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Klein AW. Contraindications and complications with the use of botulinum toxin. Clin Dermatol. 2004;22:66-75. Abstract
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Author

Joel L. Cohen, MD

Associate Clinical Professor, Department of Dermatology, University of Colorado, Denver; Director, AboutSkin Dermatology and DermSurgery; Director, The Skin Cancer Center at Swedish Medical Center, Englewood, Colorado

Disclosures

Disclosure: Joel L. Cohen, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Allergan, Inc.; DUSA Pharmaceuticals, Inc.; Biopelle, Inc.; Photocure, Inc.
Served as a speaker or a member of a speakers bureau for: Allergan, Inc.; DUSA Pharmaceuticals Inc.; Biopelle, Inc.; Graceway Pharmaceuticals, LLC
Received grants for clinical research from: Allergan, Inc.; Biopelle, Inc.; Photocure, Inc; SkinMedica, Inc.

Dr. Cohen does intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Cohen does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Kristin M. Richardson

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Kristin M. Richardson has disclosed no relevant financial relationships.

CME Reviewer/Nurse Planner

Laurie E. Scudder, DNP, NP

Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

Disclosures

Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME/CE

Aesthetic Use of Neurotoxins: Avoiding and Managing Complications

Authors: Joel L. Cohen, MD
CME/CE Released: 6/27/2011
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 6/27/2012, 11:59 PM EST

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Target Audience and Goal Statement

This activity is intended for dermatologists, plastic surgeons, primary care providers, and nurses who are involved in aesthetic procedures.

The goal of this activity is to review the safety data and established best practices associated with the aesthetic use of neurotoxins.

Upon completion of this activity, participants will be able to:

Describe and apply the safety practices established through consensus publications, clinical trials, and practice experience for the use of neurotoxins in aesthetic medicine
Develop injection strategies for the safe and effective use of neurotoxins in aesthetic treatment

Disclosures

Author

Joel L. Cohen, MD

Associate Clinical Professor, Department of Dermatology, University of Colorado, Denver; Director, AboutSkin Dermatology and DermSurgery; Director, The Skin Cancer Center at Swedish Medical Center, Englewood, Colorado

Disclosures

Disclosure: Joel L. Cohen, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Allergan, Inc.; DUSA Pharmaceuticals, Inc.; Biopelle, Inc.; Photocure, Inc.
Served as a speaker or a member of a speakers bureau for: Allergan, Inc.; DUSA Pharmaceuticals Inc.; Biopelle, Inc.; Graceway Pharmaceuticals, LLC
Received grants for clinical research from: Allergan, Inc.; Biopelle, Inc.; Photocure, Inc; SkinMedica, Inc.

Dr. Cohen does intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Cohen does intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Kristin M. Richardson

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Kristin M. Richardson has disclosed no relevant financial relationships.

CME Reviewer/Nurse Planner

Laurie E. Scudder, DNP, NP

Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

Disclosures

Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

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Editor's Note:
The botulinum neurotoxin type A (BoNTA) products available in the United States for aesthetic use are approved by the US Food and Drug Administration for temporary improvement in the appearance of moderate-to-severe glabellar lines associated with procerus and corrugator muscle activity. This program discusses off-label uses of BoNTA products.

Introduction

Botulinum toxin type A (BoNTA) injection is routinely the most common procedure reported in the American Society for Aesthetic Plastic Surgery annual survey of cosmetic procedures.^[1] Its ease of use, predictable results, and minimal recovery time are key drivers of the great demand. The widespread successful use of this agent in the United States and worldwide may lead some to trivialize the technique and skill involved in successful BoNTA injections. BoNTA is an important clinical agent, and its use in aesthetic treatment should be approached by educated clinicians who have the requisite knowledge of the complex interplay of anatomy, physiology, and aesthetic principles in order to ensure optimal outcomes.

Commercially Available BoNTA Formulations

At present, 2 injectable BoNTA formulations are approved by the US Food and Drug Administration (FDA) for aesthetic use: onabotulinumtoxinA (Botox Cosmetic®; Allergan, Inc; Irvine, California) and abobotulinumtoxinA (Dysport®; Medicis Aesthetics Inc.; Scottsdale, Arizona). IncobotulinumtoxinA (Xeomin®; Merz Pharmaceuticals, LLC; Greensboro, North Carolina), an injectable BoNTA formulated without complexing proteins (a "core neurotoxin" agent sometimes referred to as a "naked toxin"), has been approved for therapeutic use in the United States and will likely receive aesthetic approval in the near future. A novel topical BoNTA product (RT001; Revance Therapeutics; Newark, California) is in clinical trials for aesthetic use in the periorbital area. Although BoNTA options in the United States are expanding, this review will focus on the safety data and established best practices associated with the aesthetic use of onabotulinumtoxinA and abobotulinumtoxinA.

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The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on www.medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Author

Joel L. Cohen, MD

Editor

Kristin M. Richardson

CME Reviewer/Nurse Planner

Laurie E. Scudder, DNP, NP

CME/CE

Aesthetic Use of Neurotoxins: Avoiding and Managing Complications

Target Audience and Goal Statement

Disclosures

Author

Joel L. Cohen, MD

Editor

Kristin M. Richardson

CME Reviewer/Nurse Planner

Laurie E. Scudder, DNP, NP

Accreditation Statements

For Physicians

For Nurses

Instructions for Participation and Credit

Aesthetic Use of Neurotoxins: Avoiding and Managing Complications

Introduction

Commercially Available BoNTA Formulations