Botulinum toxin for glabellar lines: A review of the efficacy and safety of currently available products

American Journal of Clinical Dermatology

Volumn 12, Issue 6, 2011, Pages 377-388

  Dessy, Luca A ^a   Fallico, Nefer ^a   Mazzocchi, Marco ^b   Scuderi, Nicolò ^a  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

^b UNIVERSITY OF PERUGIA   (Italy)

Author keywords

Botulinum toxin A; Botulinum toxin B; Glabellar lines

Indexed keywords

BOTULINUM TOXIN A; BOTULINUM TOXIN B; CBTX A; CNBTX A; NEURONOX; UNCLASSIFIED DRUG; VISTABEX;

ASTHENIA; BIOEQUIVALENCE; CERVICAL DYSTONIA; CIRCULATION; CUTANEOUS PARAMETERS; DRUG BIOAVAILABILITY; DRUG DIFFUSION; DRUG DOSAGE FORM COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRY EYE; DYSPHAGIA; ESTHETICS; EYEBROW; EYELID EDEMA; FACIAL EXPRESSION; FEVER; GLABELLAR LINE; HEADACHE; HEMATOMA; HUMAN; INFECTION; INJECTION SITE BURNING; INJECTION SITE CONTUSION; INJECTION SITE DISCOMFORT; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE IRRITATION; INJECTION SITE PAIN; INJECTION SITE PARESTHESIA; INJECTION SITE PRURITUS; INJECTION SITE RASH; INJECTION SITE STINGING; INJECTION SITE SWELLING; LACRIMATION; MUSCLE DISEASE; MUSCLE FUNCTION; MUSCLE TWITCH; MUSCLE WEAKNESS; NAUSEA; OFF LABEL DRUG USE; PATIENT SATISFACTION; PRIORITY JOURNAL; PTOSIS; REVIEW; SIDE EFFECT; SKIN CARE; SKIN DEFECT; SYNCOPE; TINNITUS; TREATMENT INDICATION; VISUAL DISORDER; WRINKLE; XEROSTOMIA;

BOTULINUM TOXINS; BOTULINUM TOXINS, TYPE A; COSMETIC TECHNIQUES; FOREHEAD; HUMANS; NEUROMUSCULAR AGENTS; SKIN AGING;

EID: 80053465563     PISSN: 11750561     EISSN: 11791888     Source Type: Journal    
DOI: 10.2165/11592100-000000000-00000     Document Type: Review

References (92)

1. Pierard GE, Lapier CM. The microanatomical basis of facial frown lines. Arch Dermatol 1989; 125: 1090-2 (Pubitemid 19193129)
2. Kahn DM, Shaw RB. Overview of current thoughts on facial volume and aging. Facial Plast Surg 2010 Oct; 26 (5): 350-5
3. Charles Finn J, Cox SE, Earl ML. Social implications of hyperfunctional facial lines. Dermatol Surg 2003 May; 29 (5): 450-5 (Pubitemid 36583140)
4. MacPherson S. Self-esteem and cosmetic enhancement. Plast Surg Nurs 2005; 25 (1): 5-20
5. Leffell DJ. Foreword. In: Kaminer MS, Dover JS, Arndt KA, editors. Atlas of cosmetic surgery. 1st ed. Philadelphia (PA): W.B. Saunders Company, 2001: ix-x
6. Fagien S. Botox for the treatment of dynamic and hyperkinetic facial lines and furrows: adjunctive use in facial aesthetic surgery. Plast Reconstr Surg 1999; 103: 701-13 (Pubitemid 29071590)
7. Carruthers J, Carruthers A. The evolution of botulinum neurotoxin type A for cosmetic applications. J Cosmet Laser Ther 2007 Sep; 9 (3): 186-92 (Pubitemid 47351211)
8. Aoki KR, Guyer B. Botulinum toxin type A and other botulinum toxin serotypes: a comparative review of biochemical and pharmacological actions. Eur J Neurol 2001; 8 Suppl. 5: 21-9 (Pubitemid 33757688)
9. Aoki KR. Pharmacology and immunology of botulinum neurotoxins. Int Ophthalmol Clin 2005; 45 (3): 25-37 (Pubitemid 41022173)
10. Rizo J, Südhof TC. Mechanics of membrane fusion. Nat Struct Biol 1998 Oct; 5 (10): 839-42 (Pubitemid 28467399)
11. Blasi J, Chapman ER, Link E, et al. Botulinum neurotoxinAselectively cleaves the synaptic protein SNAP-25. Nature 1993 Sep 9; 365 (6442): 160-3 (Pubitemid 23282061)
12. Sikorra S, Henke T, Galli T, et al. Substrate recognition mechanism of VAMP/synaptobrevin-cleaving clostridial neurotoxins. J Biol Chem 2008 Jul 25; 283 (30): 21145-52
13. Dressler D, Benecke R. Pharmacology of therapeutic botulinum toxin preparations. Disabil Rehabil 2007; 29: 1761-8 (Pubitemid 350176807)
14. Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg 1989 Aug; 84 (2): 353-5 (Pubitemid 19203314)
15. Carruthers JDA, Carruthers JA. Treatment of glabellar frown lines with C. botulinum-A exotoxin. J Dermatol Surg Oncol 1992; 18 (1): 17-21
16. Blitzer A, Brin MF, Keen JS, et al. Botulinum toxin for the treatment of hyperfunctional lines of the face. Arch Otolaryngol Head Neck Surg 1993; 119: 1018-22 (Pubitemid 23270408)
17. Carruthers A, Carruthers JDA. The use of botulinum toxin to treat glabellar frown lines and other facial wrinkles. Cosmet Dermatol 1994; 7: 11-5
18. Guryuron B, Huddleston SW. Aesthetic indications for botulinum toxin injection. Plast Reconstr Surg 1994; 93: 913-8 (Pubitemid 24116581)
19. Keen M, Blitzer A, Aviv J, et al. Botulinum toxinAfor hyperkinetic facial lines: results of a double-blind, placebo-controlled study. Plast Reconstr Surg 1994; 94: 94-9 (Pubitemid 24243399)
20. Carruthers A, Carruthers JDA. Botulinum toxin in the treatment of glabellar frown lines and other facial wrinkles. In: Jankovic J, Halet M, editors. Therapy with botulinum toxin. New York (NY): Marcel Dekker, 1994: 577-95
21. Blitzer A, Binder WJ, Jonathan E, et al. The management of hyperfunctional facial lines with botulinum toxin: a collaborative study of 210 injections sites in 162 patients. Arch Otolaryngol Head Neck Surg 1997; 123: 389-92 (Pubitemid 27180937)
22. Pribitkin EA, Greco TM, Goode RL, et al. Patient selection in the treatment of glabellar wrinkles with botulinum toxin type A injection. Arch Otolaryngol Head Neck Surg 1997; 123: 321-6 (Pubitemid 27123997)
23. Carruthers A, Kiene K, Carruthers J. Botulinum A exotoxin use in clinical dermatology. J Am Acad Dermatol 1996; 34: 788-97 (Pubitemid 26137205)
24. Fagien S, Carruthers JDA. A comprehensive review of patient-reported satisfaction with botulinum toxin typeAfor aesthetic procedures. Plast Reconstr Surg 2008; 122 (6): 1915-25
25. Cox SE, Finn JC, Stetler L, et al. Development of the Facial Lines Treatment Satisfaction Questionnaire and initial results for botulinum toxin type Atreated patients. Dermatol Surg 2003; 29 (5): 444-9 (Pubitemid 36583139)
26. Stotland MA, Kowalski JW, Ray BB. Patient-reported benefit and satisfaction with botulinum toxin type A treatment of moderate to severe glabellar rhytides: results from a prospective open-label study. Plast Reconstr Surg 2007; 120 (5): 1386-93, discussion 1394 (Pubitemid 47493968)
27. Sommer B, Zschocke I, Bergfeld D, et al. Satisfaction of patients after treatment with botulinumtoxin for dynamic facial lines.Dermatol Surg 2003; 29 (5): 456-60 (Pubitemid 36583141)
28. Carruthers J, Carruthers A. Botulinum toxin type A treatment of multiple upper facial sites: patient-reported outcomes.Dermatol Surg 2007; 33 (1 Spec No.): S10-7 (Pubitemid 46051394)
29. Moy R, Maas C, Monheit G, et al. Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines. Arch Facial Plast Surg 2009 Mar-Apr; 11 (2): 77-83
30. Dessy LA, Mazzocchi M, Rubino C, et al. An objective assessment of botulinum toxin A effect on superficial skin texture. Ann Plast Surg 2007 May; 58 (5): 469-73 (Pubitemid 46659133)
31. Caputo R, Monti M, Motta S, et al. The treatment of visible signs of senescence: the Italian experience. Br J Dermatol 1990; 122 Suppl. 35: 97-103 (Pubitemid 20136116)
32. US FDA. Information for healthcare professionals: onabotulinumtoxinA (marketed as Botox-/Botox- Cosmetic), abobotulinumtoxinA (marketed as Dysport-) and rimabotulinumtoxinB (marketed as Myobloc-) [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/Postmarket DrugSafetyInformationforPatientsandProviders/DrugSafetyInformationfor HeathcareProfessionals/ucm174949.htm [Accessed 2011 Jan 5]
33. US FDA. Xeomin- FDA approval [online]. Available from URL: http://www. xeomin.com/Xeomin-FDA-Approval-Press-Release.pdf [Accessed 2011 Jan 12]
34. Carruthers A, Carruthers J. Botulinum toxin products overview. Skin Therapy Lett 2008 Jul-Aug; 13 (6): 1-4
35. US FDA. Botulinumtoxin type A product approval information: licensing action 4/12/02 [online]. Available from URL: http://www.fda.gov/Drugs/Devel opmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalAppli cations/TherapeuticBiologicApplications/ucm080509.htm [Accessed 2011 Aug 4]
36. US FDA. FDA requires boxed warning for all botulinum toxin products [online]. Available from URL: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm149574.htm [Accessed 2010 Dec 4]
37. Wiest LG. An overview of the cosmetic treatment of facial muscles with a new botulinum toxin. Acta Dermatovenerol Croat 2009; 17 (1): 48-53
38. Baumann LS, Halem ML. Botulinum toxin-B and the management of hyperhidrosis. Clin Dermatol 2004 Jan-Feb; 22 (1): 60-5 (Pubitemid 38670106)
39. Jacob CI. Botulinum neurotoxin type B: a rapid wrinkle reducer. Semin Cutan Med Surg 2003 Jun; 22 (2): 131-5 (Pubitemid 36859255)
40. US FDA. FDA gives update on botulinum toxin safety warnings; established names of drugs changed [online]. Available on URL: http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm [Accessed 2011 Jan 11]
41. Flynn TC. Myobloc. Dermatol Clin 2004 Apr; 22 (2): 207-11, vii (Pubitemid 38638575)
42. Sadick NS, Faacs. Botulinum toxin type B for glabellar wrinkles: a prospective open-label response study. Dermatol Surg 2002 Sep; 28 (9): 817-21 (Pubitemid 35014684)
43. Sadick NS. Prospective open-label study of botulinum toxin type B (Myobloc-) at doses of 2,400 and 3,000 U for the treatment of glabellar wrinkles. Dermatol Surg 2003 May; 29 (5): 501-7, discussion 507
44. Alster TS, Lupton JR. Botulinum toxin type B for dynamic glabellar rhytides refractory to botulinum toxin type A. Dermatol Surg 2003May; 29 (5): 516-8 (Pubitemid 36583150)
45. Allergan, Inc. BOTOX- (onabotulinum toxin A): US prescribing information [online]. Available from URL: http://www.allergan.com/assets/pdf/botox- cosmetic-pi.pdf [Accessed 2011 Jul 22]
46. 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 Apr; 138 (4): 510-4 (Pubitemid 34290028)
47. Hsu TS, Dover JS, Arndt KA. Effect of volume and concentration on the diffusion of botulinum exotoxin A. Arch Dermatol 2004 Nov; 140 (11) 1351-4. (Pubitemid 39473635)
48. Ranoux D, Gury C, Fondarai J, et al. Respective potencies of Botox- and Dysport-: a double blind, randomised, crossover study in cervical dystonia. J Neurol Neurosurg Psychiatry 2002 Apr; 72 (4): 459-62
49. Carruthers A, Carruthers J. Prospective, double-blind, randomized, parallelgroup, dose-ranging study of botulinum toxin type A in men with glabellar rhytids. Dermatol Surg 2005; 31 (10): 1297-303 (Pubitemid 41587037)
50. Grimes PE. A four-month randomized, double-masked evaluation of the efficacy of botulinum toxin type A for the treatment of glabellar lines in women with skin types V and VI. Poster presented at the 62nd AnnualMeeting of the American Academy of Dermatology; 2004 Feb 6-11; Washington, DC
51. Ellis DAF, Chi PL, Tan AKW. Facial rejuvenation with botulinum. Dermatol Nurs 1997; 9 (5): 329-33
52. Fagien S, Cox SE, Finn JC, et al. Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study. Dermatol Surg 2007; 33 (1 Spec No.): S2-9 (Pubitemid 46051393)
53. Naumann M, Carruthers A, Carruthers J, et al. Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX-) across multiple indications. Mov Disord 2010 Oct 15; 25 (13): 2211-8
54. Carruthers JA, Lowe NJ, Menter MA, et al. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol 2002; 46: 840-9
55. Carruthers JD, Lowe NJ, Menter MA, et al. 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: 1089-98 (Pubitemid 38251807)
56. Allergan Ltd. Vistabel-: summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/medicine/17580/SPC/vista bel/ [Accessed 2011 Jul 25]
57. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers? product summaries. J Clin Pharm Ther 2007 Aug; 32 (4): 387-402 (Pubitemid 47063164)
58. Medicis Aesthetics Inc. DYSPORT- (aboabotulinum toxin A): US prescribing information. Available from URL: http://www.dysport.com/hcp/PDFs/ prescribinginformation.pdf [Accessed 2011 Jul 22]
59. Monheit G, Carruthers A, Brandt F, et al. A randomized, double-blind, placebocontrolled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose. Dermatol Surg 2007; 33 (1 Spec No.): S51-9 (Pubitemid 46051400)
60. 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 toxinA in the treatment of glabellar lines. J Am Acad Dermatol 2004; 51 (2): 223-33
61. Rzany B, Ascher B, Fratila A, et al. Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport-) for the treatment of wrinkles in the glabella and the central forehead region. Arch Dermatol 2006; 142 (3): 320-6
62. Ascher B, Zakine B, Kestemont P, et al. Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection. Aesth Surg J 2005; 25: 365-75 (Pubitemid 41093742)
63. Brandt F, Swanson N, Baumann L, et al. Randomized, placebo-controlled study of a new botulinum toxin typeAfor treatment of glabellar lines: efficacy and safety. Dermatol Surg 2009 Dec; 35 (12): 1893-901
64. Rosales RL, Bigalke H, Dressler D. Pharmacology of botulinum toxin: differences between type A preparations. Eur J Neurol 2006; 13 Suppl. 1: 2-10
65. Karsai S, Adrian R, Hammes S, et al. A randomized, double-blind study of the effect of Botox- and Dysport-/Reloxin- on forehead wrinkles and electromyographic activity. Arch Derm 2007; 143: 1147-9
66. Karsai S, Raulin C. Current evidence on the unit equivalence of different botulinum neurotoxin A formulations and recommendations for clinical practice in dermatology. Dermatol Surg 2009; 35: 1-8
67. Wohlfarth K, Sycha T, Ranoux D, et al. Dose equivalence of two commercial preparations of botulinum neurotoxin type A: time for a reassessment? Curr Med Res Opin 2009 Jul; 25 (7): 1573-84
68. Chapman MA, Barron R, Tanis DC, et al. Comparison of botulinum neurotoxin preparations for the treatment of cervical dystonia. Clin Ther 2007; 29: 1325-37 (Pubitemid 47348118)
69. Simonetta Moreau M, Cauhepe C, Magues JP, et al. A double-blind, randomized, comparative study of Dysport vs. Botox in primary palmar hyperhidrosis. Br J Dermatol 2003; 149: 1041-5 (Pubitemid 37541992)
70. Nussgens Z, Roggenkämper P. Comparison of two botulinum toxin preparations in the treatment of essential blepharospasm. Graefes Arch Clin Exp Ophthalmol 1997; 235: 197-9 (Pubitemid 27326086)
71. Sampaio C, Ferreira JJ, Simdes F, et al. Dysbot: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A: Dysport and Botox: assuming a ratio of 4:1. Mov Disord 1997; 12: 1013-8 (Pubitemid 27496782)
72. Galderma. Azzalure-: summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/medicine/21985 [Accessed 2011 Jul 25]
73. Merz Pharma UK Ltd. Xeomin-: summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/medicine/20666 [Accessed 2011 Jul 25]
74. Merz Pharma UK Ltd. Bocouture-: summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/EMC/medicine/ 23251 [Accessed 2011 Jul 25]
75. Stenmark P, Dupuy J, Imamura A, et al. Crystal structure of botulinum neurotoxin type A in complex with the cell surface co-receptor GT1b: insight into the toxin-neuron interaction. PLoS Pathog 2008; 4 (8): e 1000129
76. Eisele KH, Taylor HV. Dissociation of the 900 kDa neurotoxin complex from C. botulinum under physiological conditions [abstract]. Toxicon 2008; 51 Suppl. 1: S10
77. Eisele KH, Grein S, Mander GJ, et al. Role of complexing proteins in pharmaceutical botulinum neurotoxin formulations. Poster no. 733 presented at the International Master Course on Aging Skin; 2009 Jan 8-11; Paris
78. Ohishi I, Sugii S, Sakaguchi G. Oral toxicities of Clostridium botulinum toxins in response to molecular size. Infect Immun 1977; 16: 107-9 (Pubitemid 8086702)
79. Chen F, Kuziemko GM, Stevens RC. Biophysical characterization of the stability of the 150-kilodalton botulinum toxin, the nontoxic component, and the 900-kilodalton botulinum toxin complex species. Infect Immun 1998; 66: 2420-5 (Pubitemid 28261733)
80. Jost WH, Kohl A, Brinkmann S, et al. Efficacy and tolerability of a botulinum toxin type A free of complexing proteins (NT 201) compared with commercially available botulinum toxin type A (Botox-) in healthy volunteers. J Neural Transm 2005; 112: 905-13 (Pubitemid 40869079)
81. Blümel J. NT 201: a new botulinum neurotoxin A. A preparation free of complexing proteins demonstrating the safety and benefit of decreased total clostridial protein burden [abstract]. J Parkinsonism Relat Disord 2005; 11 Suppl. 2: 267
82. Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics 2010 Dec 9; 4: 325-32
83. Dressler D. Pharmacological aspects of therapeutic botulinum toxin preparations. Nervenarzt 2006; 77: 912-21 (Pubitemid 44212148)
84. Grein S. Xeomin- is stable without refrigeration: complexing proteins are not required for stability of botulinum neurotoxin type A preparations [abstract]. Toxicon 2008; 13: 36
85. Dressler D, Mander G, Fink K. Equivalent potency of Xeomin- and Botox-: Movement Disorder Society's Twelfth International Congress of Parkinson's Disease and Movement Disorders [abstract]. Mov Disord 2008; 23 (S1): S20-1
86. Roggenkamper P, Jost WH, Bihari K, et al. Efficacy and safety of a new botulinum toxin type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm 2006 Mar; 113 (3): 303-12 (Pubitemid 43201097)
87. Sattler G, Callander MJ, Grablowitz D, et al. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg 2010 Dec; 36 Suppl. 4: 2146-54
88. Spencer JM, Gordon M, Goldberg DJ. Botulinum B treatment of the glabellar and frontalis regions: a dose response analysis. J Cosmet Laser Ther 2002 Mar; 4 (1): 19-23
89. Flynn TC, Clark RE. Botulinum toxin type b (Myobloc-) versus botulinum type a (Botox-) frontalis study; rate of onset and radius of diffusion. Dermatol Surg 2003 May; 29 (5): 519-22
90. Mentor Worldwide, LLC. Safety and efficacy study of PurTox- botulinum toxin type A to treat frown lines between the eyebrows (PT-03a) [Clinical- Trials.gov identifier NCT00752297]. US National Institutes of Health, ClinicalTrials. gov [online]. Available from URL: http://www.clinicaltrials.gov [Accessed 2010 Nov 23]
91. Stone AV, Ma J, Whitlock PW, et al. Effects of Botox- and Neuronox- on muscle force generation in mice. J Orthop Res 2007; 25: 1658-64
92. Hunt T, Clarke K. Potency of the botulinum toxin product CNBTX-A significantly exceeds labeled units in standard potency test. JAmAcad Dermatol 2008 Mar; 58 (3): 517-8 (Pubitemid 351226306)