Advances in Cosmetic Therapy:
A Focus on BoNT-A

Bibliography/Suggested Reading:
The attached list of clinical publications and websites used as source information for these activities provides a valuable starting point for physicians interested in obtaining more information. Bibliography and Suggested Reading Ascher B, Zakine B, Kestemont P, Baspeyras M, Bougara A, Niforos F, et al. Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection. Aesthet Surg J. 2005;25(4):365-375. Ascher B, Zakine B, Kestemont P, Baspeyras M, Bougara A, Santini J. A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2004;51(2):223-233. BOTOX Cosmetic [package insert]. Irvine, Calif: Allergan, Inc; 2009. Brandt F, Swanson N, Baumann L. Randomized, placebo-controlled study of a new botulinum toxin type A for treatment of glabellar lines: efficacy and safety. Dermatol Surg. 2009. Jun 22 [Epub ahead of print]. doi: 10.1111/j.1524-4725.2009.01235.x 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(10):1297-1303. Carruthers A, Carruthers J, Lowe NJ, et al; for the 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. 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(4):414-422. Carruthers JA, Lowe NJ, Menter MA, et al; for the BOTOX Glabellar Lines I Study Group. 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(6):840-849. Carruthers JD, Carruthers JA. Treatment of glabellar frown lines with C. botulinum-A exotoxin. J Dermatol Surg Oncol. 1992;18(1):17-21. Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N, for the 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(4):1089-1098. de Boulle K. Patient satisfaction with different botulinum toxin type A formulations in the treatment of moderate to severe upper facial rhytids. J Cosmet Laser Ther. 2008 Jun;10:87-92. De Maio M, Rzany B. Botulinum Toxin in Aesthetic Medicine. Heidelberg: Springer; 2007. DYSPORT [package insert]. Scottsdale, Arizona: Medicis Aesthetics Inc.; 2009. FDA Requires Boxed Warning for All Botulinum Toxin Products [news release]. US Food and Drug Administration; April 30, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm Accessed June 22, 2009. Hambleton P, Pickett AM. Potency equivalence of botulinum toxin preparations. J R Soc Med. 1994 Nov;87:719. Hexsel D et al. A randomized pilot study comparing the action halos of two commercial preparations of botulinum toxin type A. Dermatol Surg. 2008;34(1):52-59. Kane MA, Brandt F, Rohrich RJ, Narins RS, Monheit GD, Huber MB. 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 3, randomized, double-blind, placebo-controlled study [published online ahead of print July 28, 2009]. Plast Reconst Surg. doi:10.1097/PRS.0b013e3181b5641b Lowe PL, Patnaik R, Lowe NJ. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized, pilot study. Dermatol Surg. 2005 Dec;31:1651-1654. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006 Dec;55:975-980. Macdonald M, Spiegel J, Raven R, Kabaker S, Maas C. An anatomical approach to glabellar rhytids. Arch Otolaryngol Head Neck Surg. 1998;124:1315-1320. Monheit G, Carruthers A, Brandt F, Rand R. A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose. Dermatol Surg. 2007;33:S51-59. Monheit GD, Cohen JL; the Reloxin Investigational Group. Long-term safety of repeated administration of a new formulation of botulinum toxin type A in the treatment of glabellar lines: interim analysis from an open-label extension study. J Am Acad Dermatol. 2009;61(3):421-425. Moy R, Maas C, Monheit G, Huber MB; Reloxin Investigational Group. Long-term safety and efficacy of a new botulinum type A in treating glabellar lines. Arch Facial Plast Surg. 2009;11(2):77-83. New Proposed Risk Evaluation and Mitigation Strategy [DYSPORT]. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM150625.pdf. Accessed June 22, 2009. Panjwani N, O�Keeffe R, Pickett A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J. 2008; 1(1):153-166. Rubin MG, Dover JS, Glogau RG, Goldberg DJ, Goldman MP, 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(5):439-444. Rzany B, Ascher B, Fratila A, Monheit GD, Talarico S, Sterry W. 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):320-326. Rzany B, Nast A. Head-to-head studies of botulinum toxin A in aesthetic medicine: which evidence is good enough? J Am Acad Dermatol. 2007;56(6):1066-1067. Sesardic D, Leung T, Gaines Das R. Role for standards in assays of botulinum toxins: international collaborative study of three preparations of botulinum type A toxin. Biologicals. 2003 Dec;31:265-76. Sundaram H. Expanding the field: A new botulinum neurotoxin A enters the US arena. Practical Dermatol. 2009;6(6):17-20. Sundaram H. A practical primer for Dysport, part 2: Strategies for success with the periorbital frame and special considerations for skin of color. Practical Dermatol. 2009;6(8):33-38. Trindade de Almeida AR et al. Pilot study comparing diffusion of 2 formulations of botulinum toxin type A in patients with forehead hyperhidrosis. Dermatol Surg. 2007;33(1 Spec No):S37-S43. www.AestheticCare.org www.botoxcosmetic.com www.DysportUSA.com

Bibliography/Suggested Reading:

The attached list of clinical publications and websites used as source information for these activities provides a valuable starting point for physicians interested in obtaining more information.

Bibliography and Suggested Reading

Ascher B, Zakine B, Kestemont P, Baspeyras M, Bougara A, Niforos F, et al. Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection. Aesthet Surg J. 2005;25(4):365-375.

Ascher B, Zakine B, Kestemont P, Baspeyras M, Bougara A, Santini J. A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2004;51(2):223-233.

BOTOX Cosmetic [package insert]. Irvine, Calif: Allergan, Inc; 2009.

Brandt F, Swanson N, Baumann L. Randomized, placebo-controlled study of a new botulinum toxin type A for treatment of glabellar lines: efficacy and safety. Dermatol Surg. 2009. Jun 22 [Epub ahead of print]. doi: 10.1111/j.1524-4725.2009.01235.x

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(10):1297-1303.

Carruthers A, Carruthers J, Lowe NJ, et al; for the 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.

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(4):414-422.

Carruthers JA, Lowe NJ, Menter MA, et al; for the BOTOX Glabellar Lines I Study Group. 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(6):840-849.

Carruthers JD, Carruthers JA. Treatment of glabellar frown lines with C. botulinum-A exotoxin. J Dermatol Surg Oncol. 1992;18(1):17-21.

Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N, for the 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(4):1089-1098.

de Boulle K. Patient satisfaction with different botulinum toxin type A formulations in the treatment of moderate to severe upper facial rhytids. J Cosmet Laser Ther. 2008 Jun;10:87-92.

De Maio M, Rzany B. Botulinum Toxin in Aesthetic Medicine. Heidelberg: Springer; 2007.

DYSPORT [package insert]. Scottsdale, Arizona: Medicis Aesthetics Inc.; 2009.

FDA Requires Boxed Warning for All Botulinum Toxin Products [news release]. US Food and Drug Administration; April 30, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm

Accessed June 22, 2009.

Hambleton P, Pickett AM. Potency equivalence of botulinum toxin preparations. J R Soc Med. 1994 Nov;87:719.

Hexsel D et al. A randomized pilot study comparing the action halos of two commercial preparations of botulinum toxin type A. Dermatol Surg. 2008;34(1):52-59.

Kane MA, Brandt F, Rohrich RJ, Narins RS, Monheit GD, Huber MB. 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 3, randomized, double-blind, placebo-controlled study [published online ahead of print July 28, 2009]. Plast Reconst Surg. doi:10.1097/PRS.0b013e3181b5641b

Lowe PL, Patnaik R, Lowe NJ. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized, pilot study. Dermatol Surg. 2005 Dec;31:1651-1654.

Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006 Dec;55:975-980.

Macdonald M, Spiegel J, Raven R, Kabaker S, Maas C. An anatomical approach to glabellar rhytids. Arch Otolaryngol Head Neck Surg. 1998;124:1315-1320.

Monheit G, Carruthers A, Brandt F, Rand R. A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose. Dermatol Surg. 2007;33:S51-59.

Monheit GD, Cohen JL; the Reloxin Investigational Group. Long-term safety of repeated administration of a new formulation of botulinum toxin type A in the treatment of glabellar lines: interim analysis from an open-label extension study. J Am Acad Dermatol. 2009;61(3):421-425.

Moy R, Maas C, Monheit G, Huber MB; Reloxin Investigational Group. Long-term safety and efficacy of a new botulinum type A in treating glabellar lines. Arch Facial Plast Surg. 2009;11(2):77-83.

New Proposed Risk Evaluation and Mitigation Strategy [DYSPORT]. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM150625.pdf. Accessed June 22, 2009.

Panjwani N, O�Keeffe R, Pickett A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J. 2008; 1(1):153-166.

Rubin MG, Dover JS, Glogau RG, Goldberg DJ, Goldman MP, 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(5):439-444.

Rzany B, Ascher B, Fratila A, Monheit GD, Talarico S, Sterry W. 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):320-326.

Rzany B, Nast A. Head-to-head studies of botulinum toxin A in aesthetic medicine: which evidence is good enough? J Am Acad Dermatol. 2007;56(6):1066-1067.

Sesardic D, Leung T, Gaines Das R. Role for standards in assays of botulinum toxins: international collaborative study of three preparations of botulinum type A toxin. Biologicals. 2003 Dec;31:265-76.

Sundaram H. Expanding the field: A new botulinum neurotoxin A enters the US arena. Practical Dermatol. 2009;6(6):17-20.

Sundaram H. A practical primer for Dysport, part 2: Strategies for success with the periorbital frame and special considerations for skin of color. Practical Dermatol. 2009;6(8):33-38.

Trindade de Almeida AR et al. Pilot study comparing diffusion of 2 formulations of botulinum toxin type A in patients with forehead hyperhidrosis. Dermatol Surg. 2007;33(1 Spec No):S37-S43.

Advances in Cosmetic Therapy: A Focus on BoNT-A

Advances in Cosmetic Therapy:
A Focus on BoNT-A