Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

Summary

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

Timeline

Start

2011-08

Primary completion

2011-10

Completion

2012-09

Publications

• Background Jankovic J, Brin MF. Botulinum toxin: historical perspective and potential new indications. Muscle Nerve Suppl. 1997;6:S129-45.
• Background Nigam PK, Nigam A. Botulinum toxin. Indian J Dermatol. 2010;55(1):8-14. doi: 10.4103/0019-5154.60343.
• Background Yang GH, Jung HH. A new botulinum toxin potentially bioequivalent to onabotulinumtoxinA: are there any differences at all? Dermatol Surg. 2013 Jan;39(1 Pt 2):165-70. doi: 10.1111/dsu.12073. No abstract available.
• Background Zagui RM, Matayoshi S, Moura FC. [Adverse effects associated with facial application of botulinum toxin: a systematic review with meta-analysis]. Arq Bras Oftalmol. 2008 Nov-Dec;71(6):894-901. doi: 10.1590/s0004-27492008000600027. Portuguese.
• Background Sposito MMM. Toxina botulínica do tipo A: mecanismo de ação. Acta Fisiatr. 2009;16(1):25-37.
• Background Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; 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 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
• Background Small R. Botulinum toxin injection for facial wrinkles. Am Fam Physician. 2014 Aug 1;90(3):168-75.
• Background Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
• Background Hexsel D, Mazzuco R, Dal'Forno T, Kraemer C, Lima MM, Prado DZ. Botulinum toxin for Facial Wrinkles: History and Future. Expert Rev. Dermatol. 2(4), 417 - 426 (2007).
• Background Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; 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 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.
• Background De Boulle K, Fagien S, Sommer B, Glogau R. Treating glabellar lines with botulinum toxin type A-hemagglutinin complex: a review of the science, the clinical data, and patient satisfaction. Clin Interv Aging. 2010 Apr 26;5:101-18. doi: 10.2147/cia.s9338.
• Background Carruthers A, Carruthers J, Cohen J. A prospective, double-blind, randomized, parallel- group, dose-ranging study of botulinum toxin type a in female subjects with horizontal forehead rhytides. Dermatol Surg. 2003 May;29(5):461-7. doi: 10.1046/j.1524-4725.2003.29114.x.
• Background Honeck P, Weiss C, Sterry W, Rzany B; Gladys study group. Reproducibility of a four-point clinical severity score for glabellar frown lines. Br J Dermatol. 2003 Aug;149(2):306-10. doi: 10.1046/j.1365-2133.2003.05436.x.
• Background Dolly, JO. Therapeutic and Research Exploitation of Botulinum Neurotoxins. Eur J Neurol. 1997;4:S5-10.
• Background Yoon JS, Kim JC, Lee SY. Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm. Korean J Ophthalmol. 2009 Sep;23(3):137-41. doi: 10.3341/kjo.2009.23.3.137. Epub 2009 Sep 8.
• Background Kim K, Shin HI, Kwon BS, Kim SJ, Jung IY, Bang MS. Neuronox versus BOTOX for spastic equinus gait in children with cerebral palsy: a randomized, double-blinded, controlled multicentre clinical trial. Dev Med Child Neurol. 2011 Mar;53(3):239-44. doi: 10.1111/j.1469-8749.2010.03830.x. Epub 2010 Nov 18.
• Background Wollmer MA, de Boer C, Kalak N, Beck J, Gotz T, Schmidt T, Hodzic M, Bayer U, Kollmann T, Kollewe K, Sonmez D, Duntsch K, Haug MD, Schedlowski M, Hatzinger M, Dressler D, Brand S, Holsboer-Trachsler E, Kruger TH. Facing depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res. 2012 May;46(5):574-81. doi: 10.1016/j.jpsychires.2012.01.027. Epub 2012 Feb 24.
• Background Ascher B, Rzany BJ, Grover R. Efficacy and safety of botulinum toxin type A in the treatment of lateral crow's feet: double-blind, placebo-controlled, dose-ranging study. Dermatol Surg. 2009 Oct;35(10):1478-86. doi: 10.1111/j.1524-4725.2009.01261.x. Epub 2009 Jul 20.
• Background Beer KR. Comparative evaluation of the safety and efficacy of botulinum toxin type A and topical creams for treating moderate-to-severe glabellar rhytids. Dermatol Surg. 2006 Feb;32(2):184-97. doi: 10.1111/j.1524-4725.2006.32036.x.
• Background Jones D, Carruthers J, Narins RS, Coleman WP 3rd, Harrington L, Brandt FS, Cohen JL. Efficacy of incobotulinumtoxinA for treatment of glabellar frown lines: a post hoc pooled analysis of 2 randomized, placebo-controlled, phase 3 trials. Dermatol Surg. 2014 Jul;40(7):776-85. doi: 10.1111/dsu.0000000000000001.
• Background Won CH, Lee HM, Lee WS, Kang H, Kim BJ, Kim WS, Lee JH, Lee DH, Huh CH. Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines: a randomized, double-blind, active-controlled multicenter study. Dermatol Surg. 2013 Jan;39(1 Pt 2):171-8. doi: 10.1111/dsu.12072.
• Background RDC 55 - Agência Nacional de Vigilância Sanitária. Registro de Produtos Biológicos | Bases Legais e Guias - Coletânea -459p.: il.; graf.; tab. ISBN.
• Background Ferreira LM, Filho ST, Costa RO, Godoy A, Steiner D, Fleissig L, et al. Eficácia e tolerabilidade de uma nova toxina botulínica tipo A para tratamento estético de rugas faciais dinâmicas: estudo multicêntrico prospectivo de fase III. Surgical & Cosmetic Dermatology 2009;1(2): 58-63.
• Background Filho ST, Bagatin E, Monteiro EO, Pinheiro MVB, Hassun KM. Eficácia e segurança da neurotoxina botulínica tipo A* no tratamento de linhas de expressão glabelares. RBM rev. bras. med;65(n.esp):28-33, out. 2008.
• Background Rappl T, Parvizi D, Friedl H, Wiedner M, May S, Kranzelbinder B, Wurzer P, Hellbom B. Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. Clin Cosmet Investig Dermatol. 2013 Sep 24;6:211-9. doi: 10.2147/CCID.S41537. eCollection 2013.
• Background Gracies JM, Simpson DM. Botulinum toxin therapy. Neurologist 6:98,2000.

Drugs

Indications

No indication recorded.