Clinical trial NCT01180348 - References

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

Citation(s)

•   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.
•   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.
•   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.
•   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.
•   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.
•   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. Review.
•   Dolly, JO
  Therapeutic and Research Exploitation of Botulinum Neurotoxins. Eur J Neurol. 1997;4:S5-10.
•   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.
•   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.
•   Gracies JM, Simpson DM
  Botulinum toxin therapy. Neurologist 6:98,2000.
•   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).
•   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.
•   Jankovic J, Brin MF
  Botulinum toxin: historical perspective and potential new indications. Muscle Nerve Suppl. 1997;6:S129-45.
•   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.
•   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.
•   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.
•   Nigam PK, Nigam A
  Botulinum toxin. Indian J Dermatol. 2010;55(1):8-14. doi: 10.4103/0019-5154.60343.
•   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.
•   RDC 55 - Agência Nacional de Vigilância Sanitária
  Registro de Produtos Biológicos | Bases Legais e Guias - Coletânea -459p.: il.; graf.; tab. ISBN.
•   Small R
  Botulinum toxin injection for facial wrinkles. Am Fam Physician. 2014 Aug 1;90(3):168-75. Review.
•   Sposito MMM
  Toxina botulínica do tipo A: mecanismo de ação. Acta Fisiatr. 2009;16(1):25-37.
•   Wollmer MA, de Boer C, Kalak N, Beck J, Götz T, Schmidt T, Hodzic M, Bayer U, Kollmann T, Kollewe K, Sönmez 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.
•   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.
•   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. Review. Erratum in: Dermatol Surg. 2013 Jun;39(6):965.
•   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.
•   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. Review. Portuguese.

Randomized Study of Clinical Non-inferiority of Medicine Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) Compared to Botox ® (Allergan Inc.) in the Improvement of Wrinkles in the Facial Region.

Details for clinical trial NCT01180348