OnabotulinumtoxinA Dose-Ranging Study for Hyperdynamic Perioral Lines

Background Few dosing data on onabotulinumtoxinA to treat hyperdynamic perioral lines (POLs) are available. Studying onabotulinumtoxinA in controlled settings is beneficial to treating a hyperfunctional orbicularis oris. Objective To compare the dose-response relationship of two doses of onabotulinumtoxinA in hyperdynamic POLs. Methods Female subjects (N similar to=similar to 60) received injections of onabotulinumtoxinA at four sites totaling 7.5 similar to U or 12.0 similar to U. Subjects returned at weeks 2, 4, 8, 12, 16, and 20. POL severity and total lip satisfaction (TLS) were assessed at all visits. Results Investigator-assessed POL severity was reduced through week 20 for 12.0 similar to U (p similar to<similar to.01). POL reduction for 7.5 similar to U persisted until week 16 (p similar to<similar to.05). Responder rates did not differ until week 12 (12.0 similar to U, 77%; 7.5 similar to U, 36%; p similar to=similar to.003). Subject-assessed TLS was improved (p similar to<similar to.05) at all time points for both groups except at week 20 (12.0 similar to U; p similar to=similar to.06). Most adverse events (AEs) were mild to moderate in severity and typical for onabotulinumtoxinA treatment in the lips, and the incidence was dose-dependent. Conclusion OnabotulinumtoxinA provides significant reductions in POL severity and high levels of subject satisfaction. Lack of dose response and fewer AEs suggest that treatment of hyperdynamic POLs with 7.5 similar to U appears adequate for up to 16 similar to weeks.