Top-line results from a Phase 2 dose escalation study show that significantly more subjects treated with Dysport® at all four doses achieved a composite two grade improvement responder rate than those treated with placebo at one month.
The study accessed the duration of effect and the efficacy and safety of a single dose of Dysport (abobotulinumtoxinA) at four different doses versus placebo for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines).
Data for secondary endpoints, reported by Galderma, demonstrate promising results for a potential prolonged duration of effect correlated with higher doses.
"We are encouraged that these study results demonstrate that a single dose of Dysport has a rapid onset, long-lasting effect and is well tolerated," said John H. Joseph, MD, investigator for the study and director of The Clinical Testing Center of Beverly Hills. "At all doses tested in the trial, Dysport had a strong safety profile, including very few cases of eyelid ptosis."
The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Study participants were randomized 4:1 to receive a single dose of Dysport (50U, 75U, 100U, or 125U) or placebo and followed for nine months.