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| |  AAD: Botox (Botulinum Toxin Type A) May Reduce Glabellar Lines, Longer Duration Of Effect After Treatment WASHINGTON, DC -- March 5, 2001 -- Results from a large, long-term study of patients receiving subsequent injections suggest that Botox® (botulinum toxin type A) may reduce brow furrow (glabellar lines) -- deep lines between the eyebrows - and lasts longer with each additional treatment. The study was presented here at the 59th annual meeting of the American Academy of Dermatology (AAD). Glabellar lines occur when the facial muscles between the eyebrows are overactive, or contract more than normal, causing the skin between the eyes to continuously appear wrinkled or deeply furrowed. "These encouraging findings suggest that subsequent Botox usage may actually relax the muscles, causing the wrinkles to disappear," said Alastair Carruthers, MD, lead study investigator. "Many current treatments, such as chemical peels and other resurfacing techniques have a more superficial effect and don't get to the root of the problem." Findings from another study, which examined the effectiveness of Botox on crow's feet -- deep lines on the sides of the eyes -- also appeared to suggest that the effects last longer after each additional treatment. This study also was presented at the AAD meeting. The study consisted of a four-month, double-blind, vehicle-controlled phase (period one), followed by an eight-month, open label, extension phase (period two). A total of 535 patients were enrolled in period one, 245 of whom continued onto period two. In period one, patients were evaluated on days 7, 30, 60, 90, and 120. In period two, which consisted of two injections 120 days apart, patients were evaluated at 30-day intervals after each injection. During period one, 80 percent of Botox -treated patients with either moderate or severe glabellar lines had either mild or no lines at maximum frown during the 30-day evaluation, compared to 1.5 percent of patients in the vehicle group. Patients with at least mild glabellar lines at the end of period one were offered enrollment into period two. Eighty-five percent of Botox -treated patients after the first follow-up injection, evaluated at day 30 after the injection, had either mild or no lines, compared to 5.4 percent of patients in the vehicle group. And following the second follow-up injection in Phase 2 of the study, eighty-nine percent of Botox-treated patients, evaluated at day 30 after that injection, had either mild or no lines. The percentage of patients who responded to treatment increased significantly for all efficacy measures -- physician and patient assessment of glabellar line severity -- with each successive injection during period two. There were no significant differences in any adverse events between the treatment groups during period one. Drooping of the upper eyelid (blepharoptosis), a possible side effect of Botox that affected a very small percentage of patients, decreased across both periods with each successive treatment. Side effects were generally mild. Botox is indicated for the treatment of strabismus, blepharospasm associated with dystonia (disorder of the eye muscles that control blinking), and cervical dystonia (involuntary muscle spasms in the neck and shoulders). In addition, Botox currently is being studied as a treatment for a number of other neurological disorders and dermatological conditions.
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