Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study

Summary

The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin. The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles \[0\], very fine wrinkles \[1\], fine wrinkles \[2\], moderate wrinkles \[3\] or severe wrinkles \[4\]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.

Timeline

Start

2009-09

Primary completion

2012-09

Completion

2014-09

Publications

• Background Elson ML. Evaluation and treatment of the aging face. In: Evaluation and Treatment of the Aging Face. Elson MD, ed. Springer-Verlag, New York, 1995, 1-9.
• Background Lowe NJ. Botulinum toxin type A for facial rejuvenation. United States and United Kingdom perspectives. Dermatol Surg. 1998 Nov;24(11):1216-8. doi: 10.1111/j.1524-4725.1998.tb04100.x.
• Background Guerrissi J, Sarkissian P. Local injection into mimetic muscles of botulinum toxin A for the treatment of facial lines. Ann Plast Surg. 1997 Nov;39(5):447-53. doi: 10.1097/00000637-199711000-00002.
• Background Foster JA, Barnhorst D, Papay F, Oh PM, Wulc AE. The use of botulinum A toxin to ameliorate facial kinetic frown lines. Ophthalmology. 1996 Apr;103(4):618-22. doi: 10.1016/s0161-6420(96)30644-1.
• Background Guyuron B, Huddleston SW. Aesthetic indications for botulinum toxin injection. Plast Reconstr Surg. 1994 Apr;93(5):913-8. doi: 10.1097/00006534-199404001-00003.
• Background Blitzer A, Brin MF, Keen MS, Aviv JE. Botulinum toxin for the treatment of hyperfunctional lines of the face. Arch Otolaryngol Head Neck Surg. 1993 Sep;119(9):1018-22. doi: 10.1001/archotol.1993.01880210108015.
• Background Carruthers JD, Carruthers JA. Treatment of glabellar frown lines with C. botulinum-A exotoxin. J Dermatol Surg Oncol. 1992 Jan;18(1):17-21. doi: 10.1111/j.1524-4725.1992.tb03295.x.
• Background Fagien S. Botox for the treatment of dynamic and hyperkinetic facial lines and furrows: adjunctive use in facial aesthetic surgery. Plast Reconstr Surg. 1999 Feb;103(2):701-13. doi: 10.1097/00006534-199902000-00055.
• Background Ramirez AL, Reeck J, Maas CS. Botulinum toxin type B (MyoBloc) in the management of hyperkinetic facial lines. Otolaryngol Head Neck Surg. 2002 May;126(5):459-67. doi: 10.1067/mhn.2002.124706.
• Background Kim EJ, Ramirez AL, Reeck JB, Maas CS. The role of botulinum toxin type B (Myobloc) in the treatment of hyperkinetic facial lines. Plast Reconstr Surg. 2003 Oct;112(5 Suppl):88S-93S; discussion 94S-97S. doi: 10.1097/01.PRS.0000082197.88799.84.
• 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 Ascher B, Klap P, Marion MH, Chanteloub F. [Botulinum toxin in the treatment of frontoglabellar and periorbital wrinkles. An initial study]. Ann Chir Plast Esthet. 1995 Feb;40(1):67-76. French.
• Background Ascher B. Facial rejuvenation by non-endoscopic lifting and botulinum toxin injection. Les Cahiers D'Ophthalmologie 2000;45:25-31.
• Background Olver JM. Botulinum toxin A treatment of overactive corrugator supercilii in thyroid eye disease. Br J Ophthalmol. 1998 May;82(5):528-33. doi: 10.1136/bjo.82.5.528.
• Background Erian A, Ionescu NE. Combination treatment of glabellar rhytids. Int J Cosmetic Surg 1999;7(1):14-17.
• Background Feller G, Bayerl C, Jung E, Rzany B. Treatment of dynamic facial wrinkles with botulinum toxin type A (Dysport®)-a pilot study. Akt Deramtol 2000;26:65-9.
• Background Le Louarn C. [Botulinum toxin and facial wrinkles: a new injection procedure]. Ann Chir Plast Esthet. 1998 Oct;43(5):526-33. French.
• Background Altman DG. How large a sample? Statistics in Practice. London, UK: British Medical Association 1982.
• Background McLarty JW, Levine RJ. How many subjects are required for a study? IRB. 1987 Sep-Oct;9(5):1-3. No abstract available.

Drugs

Indications