September 24, 2010
Dysport Data Shows Superiority Versus Botox Cosmetic
Green Room Public Relations
NEW STUDY DATA PRESENTED AT THE AMERICAN ACADEMY OF FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY 2010 ANNUAL FALL MEETING REVEAL
DYSPORT™ SUPERIORITY VERSUS BOTOX® COSMETIC
Clinical Results Show Efficacy Benefit with Dysport™ for Treatment of Crow’s Feet
ALEXANDRIA, VA (SEPTEMBER 24, 2010)
At the American Academy of Facial Plastic and Reconstructive Surgery annual meeting, clinical results were presented demonstrating a significant efficacy advantage with Dysport™ (abobotulinumtoxinA) over Botox® Cosmetic (onabotulinumtoxinA) for the treatment of Crow’s feet. The data were presented Friday, September 24 at a scientific session at the AAFPRS 2010 Annual Fall Meeting, taking place September 23-26 in Boston.The 90-subject study, titled “Internally Controlled Double-Blind Comparison of Onabotulinum and Abobotulinum Toxin Type A (Nettar, Kartik D., M.D., et. al),” met its primary endpoint (p=0.01) of greater efficacy of action with Dysport™ as defined by investigator assessment of maximum contraction at Day 30 post injection compared to Day 0. Additionally, a secondary endpoint—subject assessment at maximum contraction at Day 30 compared to Day 0—also demonstrated statistical significance with Dysport™ (p=0.027).
“Botox has long been considered the gold standard of injectables, so this data showing Dysport’s stronger efficacy is compelling,” said Corey S. Maas, M.D., F.A.C.S., AAFPRS Group Vice President for Public and Regulatory Affairs. “Since injectables are the non-surgical cosmetic procedure rising fastest in popularity, it is important to continue honing new applications for existing treatments. Dysport’s potential here is exciting as Crow’s feet are a common concern for many men and women.”
The study concluded that Dysport™ offers a quantifiable and demonstrable advantage in wrinkle effacement (shortening) and hyperfunctional frown lines compared to Botox® Cosmetic in the treatment of Crow’s feet. Study investigators recommend further studies in additional facial regions to confirm the data.
Both Botox® Cosmetic and Dysport™ are FDA approved for treatment of moderate-to-severe glabellar lines (vertical lines between the eyebrows); neither product is presently indicated for treatment of Crow’s feet. Both Allergan and Medicis Aesthetics were approached and offered the opportunity to provide research grants for the study. Medicis Aesthetics provided a research grant, Allergan declined. Additionally, none of the study investigators received compensation.
Additional Study Information: The randomized, double-blind, internally-controlled (split face) study was conducted at the Maas Clinic in California. Ninety subjects (75 females, 15 males) with moderate-to-severe lateral orbital rhytids (Crow’s feet) were enrolled in the study. Participants received equivalent doses of both treatments: 10 units of Botox® Cosmetic on one side of the face and 30 units of Dysport™ on the other side. Investigator and subject gradings of Crow’s feet at relaxation and maximal contraction were obtained using the published validated dynamic and static Merz Crow’s feet grading scale before injection (Day 0) and then two, four, six, and 30 days post injection. All patients were photographed in standard five-view series at rest and at maximal contraction in a dedicated photo lane recorded by Mirror software. Additional secondary endpoints not met in the study include investigator assessment at rest at Day 30 (p=0.41) and subject assessment at rest at Day 30 (p=0.28).
About The AAFPRS: The AAFPRS is the world's largest association of facial plastic and reconstructive surgeons with more than 2,700 members— whose cosmetic reconstructive surgery focuses on the face, head and neck. Academy fellows and members are board-certified and subscribe to a code of ethics. In addition, the AAFPRS provides consumers with free information and brochures and a list of qualified facial plastic surgeons in their area by visiting the AAFPRS website, www.facemd.org.
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