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 - 24/08/11
, Benjamin Zakine, MD b, Philippe Kestemont, MD c, Martine Baspeyras, MD d, Ali Bougara, MD a, José Santini, MD c
Reprint requests: Benjamin Ascher, MD, Clinique de Chirurgie Esthétique Iéna, 11 rue Fresnel, 75016 Paris, France.Saint-Cloud, Paris, Nice, and Bordeaux, France
Abstract |
Background |
Botulinum toxin A (BTX-A) is used to treat glabellar lines but the rigorous demonstration of its efficacy in a well-designed study had never been reported.
Objective |
This study was designed to evaluate the efficacy and the safety of 3 doses of BTX-A in the treatment of glabellar lines.
Methods |
A total of 119 patients with moderate to severe glabellar lines at rest were treated with 25, 50, or 75 U of BTX-A (Dysport, Ipsen) or placebo divided into 5 intramuscular glabellar sites. Outcome measures included evaluations of glabellar lines by independent experts from blinded standardized photographs at rest 1 month after treatment, physician evaluations, and patient assessments during a 6-month period.
Results |
A significant efficacy was reported for the 3 BTX-A groups for at least 3 months after injection (at least P < .015). Investigator and patient evaluations suggested that 50 U was the optimal dose. BTX-A was well tolerated. No blepharoptosis was reported. An evaluation in blinded conditions by independent experts was necessary because the results were overestimated by the investigators.
Conclusion |
BTX-A is an effective and safe treatment for glabellar lines.
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, BTX-A, MITT
Plan
 | Supported by Beaufour Ipsen Pharma SAS. Disclosure: Dr Zakine is an employee of Beaufour Ipsen Pharma SAS. Presented at the Botulinum Toxin Aesthetic Indications International Workshop in Paris, France, May 2003, and the European Academy of Dermatology and Venereology Meeting in Barcelona, Spain, October 2003. |
Vol 51 - N° 2
P. 223-233 - août 2004 Retour au numéro
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