A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines - 01/09/11
BOTOX Glabellar Lines I Study Group*
Abstract |
Background: Botulinum toxin type A (BTX-A) is widely used for facial esthetics but is incompletely studied. Objective: This study was conducted to evaluate the efficacy and safety of BTX-A treatment of glabellar lines. Methods: Patients with moderate to severe glabellar lines at maximum frown received intramuscular injections of 20 U BTX-A (BOTOX, Allergan, Inc, Irvine, Calif) or placebo into 5 glabellar sites. Patients were followed up for 120 days after injection. Outcome measures were physician rating of glabellar line severity at maximum frown and rest, patient assessment of improvement, and vital sign and adverse event monitoring. Results: Two hundred sixty-four patients were enrolled (BTX-A: 203, placebo: 61). There was a significantly greater reduction in glabellar line severity with BTX-A than with placebo (all measures, every follow-up visit; P < .022). The effect was maintained for many patients through day 120. There was a low occurrence (5.4%) of mostly mild blepharoptosis in the BTX-A group. Conclusion: BTX-A injections are safe and effective in reducing the severity of glabellar lines. (J Am Acad Dermatol 2002;46:840-9.)
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 | *A complete list of the members of the BOTOX Glabellar Lines I Study Group appears at the end of this article. |
| Funding sources: Allergan, Inc. |
 | Disclosure: Drs Carruthers and Lowe are paid consultants of Allergan, Inc. Dr Carruthers is also a consultant for a company that makes a competitive product to the one used in this study. Marian Nordquist, Julie Mordaunt, John Gibson, Patricia Walker, and Nina Eadie are employees of Allergan, Inc. |
| Reprint requests: Nina Eadie, Allergan, Inc, 2525 Dupont Dr, Irvine, CA 92623-9534. |
Vol 46 - N° 6
P. 840-849 - juin 2002 Retour au numéro
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