Field effect of two commercial preparations of botulinum toxin type A: A prospective, double-blind, randomized clinical trial

Journal of the American Academy of Dermatology

Volumn 67, Issue 2, 2012, Pages 226-232

  Hexsel, Doris ^a,b   Brum, Cristiano ^a,e   Do Prado, Débora Zechmeister ^a   Soirefmann, Mariana ^a,b   Rotta, Francisco Telechea ^d   Dal'Forno, Taciana ^a,b   Rodrigues, Ticiana C ^a,c  

^a Brazilian Center for Studies in Dermatology   (Brazil)

^b PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^c HOSPITAL DE CLÍNICAS DE PORTO ALEGRE   (Brazil)

^d HOSPITAL MOINHOS DE VENTO   (Brazil)

^e Complexo Hospitalar Santa Casa ^*  (Brazil)

Author keywords

anhidrotic action halos; botulinum toxin type A; dose equivalence; field effect

Indexed keywords

BOTULINUM TOXIN A;

ANHIDROSIS; ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ELECTROMYOGRAPHY; FEMALE; HUMAN; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SWEAT GLAND; WRINKLE;

ACTION POTENTIALS; ADOLESCENT; ADULT; BOTULINUM TOXINS, TYPE A; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FACIAL MUSCLES; FEMALE; FOREHEAD; HUMANS; MIDDLE AGED; NEUROTOXINS; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; SKIN AGING; SWEAT GLANDS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84863988492     PISSN: 01909622     EISSN: 10976787     Source Type: Journal    
DOI: 10.1016/j.jaad.2011.08.011     Document Type: Article

References (33)

1. F. Durif Clinical bioequivalence of the current commercial preparations of botulinum toxin Eur J Neurol 2 1996 17 18
2. S.L. Matarasso Comparison of botulinum toxin types A and B: a bilateral and double-blind randomized evaluation in the treatment of canthal rhytides Dermatol Surg 29 2003 7 13 (Pubitemid 36118846)
3. N.J. Lowe Botulinum toxin type A for facial rejuvenation Dermatol Surg 24 1998 1216 1218
4. P. Moore, and M. Naumann General and clinical aspects of treatment with botulinum toxin P. Moore, M. Naumann, Handbook of botulinum toxin treatment 2nd ed. 2003 Blackwell Science Oxford 28 75
5. M.M.M. Sposito New indications for botulinum toxin type A in cosmetics: mouth and neck Plast Reconstr Surg 110 2002 601 611 (Pubitemid 34815968)
6. Hexsel D, Rodrigues TC, Zechmeister-Prado D, Gamboa ML. A phase IV controlled randomized double-blinded study on the anhydrotic action halos and muscle activity of two commercial preparations type A botulinum toxin administered to the upper third of the face. Poster presented at: 67th American Academy of Dermatology Meeting; March 6-11, 2009; San Francisco, CA.
7. K. Wohlfarth, I. Schwandt, F. Wegner, T. Jürgens, G. Gelbrich, and A. Wagner Biological activity of two botulinum toxin types A complexes (Dysport and Botox) in volunteers: a double-blind, randomized, dose-ranging study J Neurol 255 2008 1932 1939
8. D. Hexsel, T.C. Rodrigues, M. Soirefmann, and D. Zechmeister-Prado Recommendations for performing and evaluating the results of minor's test according to a sweating intensity visual scale Dermatol Surg 36 2010 120 122
9. R.G. Glogau Aesthetic and anatomic analysis of the aging skin Semin Cutan Med Surg 15 1996 134 138 (Pubitemid 27197973)
10. V. Minor Ein Neues Verfahren zu der klinischen Untersuchung der Schweissabsonderung Z Neurol 101 1927 302 308
11. D.M. Hexsel, M. Soirefmann, T.C. Rodrigues, and D.Z. do Prado Increasing the field effects of similar doses of Clostridium botulinum type A toxin-hemagglutinin complex in the treatment of compensatory hyperhidrosis Arch Dermatol 145 2009 837 840
12. S.H. Cliff, H. Judodihardjo, and E. Eltringham Different formulations of botulinum toxin type A have different migration characteristics: a double-blind, randomized study J Cosmet Dermatol 7 2008 50 54 (Pubitemid 351228167)
13. A.R. Trindade de Almeida, E. Marques, J. Almeida, T. Cunha, and R. Boraso Pilot study comparing the diffusion of two formulations of botulinum toxin type A in patients with forehead hyperhidrosis Dermatol Surg 33 2007 S37 S43
14. S. Karsai, and C. Raulin Do different formulations of botulinum toxin type A really have different migration characteristics [letter]? J Cosmet Dermatol 7 2008 230
15. S. Karsai, and C. Raulin Botox and Dysport: is there a dose conversion ratio in dermatology and aesthetic medicine? J Am Acad Dermatol 62 2010 346 347
16. S. Karsai, R. Adrian, S. Hammes, J. Thimm, and C. Raulin A randomized double-blind study of the effect of Botox and Dysport/Reloxin on forehead wrinkles and electromyographic activity Arch Dermatol 143 2007 1447 1449 (Pubitemid 350146281)
17. A. Carruthers, M. Bogle, J.D. Carruthers, J.S. Dover, K.A. Arndt, and T.S. Hsu A randomized, evaluator-blinded, two-center study of the safety and effect of volume on the diffusion and efficacy of botulinum toxin type A in the treatment of lateral orbital rhytides Dermatol Surg 33 2007 567 571 (Pubitemid 46650366)
18. A.T. de Almeida, and K.J. De Boulle Diffusion characteristics of botulinum neurotoxin products and their clinical significance in cosmetic applications J Cosmet Laser Ther 9 Suppl 2007 17 22 (Pubitemid 47450877)
19. E.C. Lim, and R.C. Seet Botulinum toxin: description of injection techniques and examination of controversies surrounding toxin diffusion Acta Neurol Scand 117 2008 73 84
20. A.P. de Sa Earp, and E.S. Marmur The five D's of botulinum toxin: doses, dilution, diffusion, duration and dogma J Cosmet Laser Ther 10 2008 93 102 (Pubitemid 351883325)
21. R. Eleopra, V. Tugnoli, L. Caniatti, and D. De Grandis Botulinum toxin treatment in the facial muscles of humans: evidence of an action in untreated near muscles by peripheral local diffusion Neurology 46 1996 1158 1160 (Pubitemid 26134671)
22. A. Pickett Dysport: pharmacological properties and factors that influence toxin action Toxicon 54 2009 683 689
23. A. Pickett, S. Dodd, and B. Rzany Confusion about diffusion and the art of misinterpreting data when comparing different botulinum toxins used in aesthetic applications J Cosmet Laser Ther 10 2008 181 183
24. L. Carli, C. Montecucco, and O. Rossetto Assay of diffusion of different botulinum neurotoxin type A formulations injected in the mouse leg Muscle Nerve 40 2009 374 380
25. M. Yaraskavitch, T. Leonard, and W. Herzog Botox produces functional weakness in non-injected muscles adjacent to the target muscle J Biomech 41 2008 897 902
26. N. Roche, A. Schnitzler, F.F. Genêt, M.C. Durand, and D. Bensmail Undesirable distant effects following botulinum toxin type a injection Clin Neuropharmacol 31 2008 272 280
27. P. Hambleton, and A.M. Pickett Potency equivalence of botulinum toxin preparations J R Soc Med 87 1994 719 (Pubitemid 24334671)
28. P. Schnider, E. Moraru, H. Kittler, B. Voller, G. Kranz, and E. Auff Botulinum toxin in the treatment of focal hyperhidrosis Wien Klin Wochenschr 113 2001 36 41 (Pubitemid 33015391)
29. B. Ascher, B. Zakine, P. Kestemont, M. Baspeyras, A. Bougara, and J. Santini 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 51 2004 223 233
30. K. Wohlfarth, T. Sycha, D. Ranoux, H. Naver, and D. Caird Dose equivalence of two commercial preparations of botulinum neurotoxin type A: time for a reassessment? Curr Med Res Opin 25 2009 1573 1584
31. D. Hexsel, T. Dal'Forno, C. Hexsel, D. Zechmeister-Prado, and M.M. Lima A randomized pilot study comparing the action halos of two commercial preparations of botulinum toxin type A Dermatol Surg 34 2008 52 59 (Pubitemid 350308586)
32. S. Karsai, and C. Raulin Current evidence on the unit equivalence of different botulinum neurotoxin A formulations and recommendations for clinical practice in dermatology Dermatol Surg 35 2009 1 8
33. M. Heckmann, and G. Plewig Hyperhidrosis Study Group. Low-dose efficacy of botulinum toxin A for axillary hyperhidrosis: a randomized, side-by-side, open-label study Arch Dermatol 141 2005 1255 1259 (Pubitemid 41498923)