Increased incobotulinumtoxinA doses prolong frown line reduction

IncobotulinumtoxinA was effective and safe in the reduction of glabellar frown lines at multiple dose levels, with higher doses achieving prolonged results, according to phase 2 study results.

A 20-unit dose of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals), a botulinum toxin A product, is currently FDA approved in the United States, while a 20- to 30-unit dose is approved for use in the European Union.

“There is an increasing demand for a longer duration of effect from botulinum toxin A (BoNT/A) products. [IncobotulinumtoxinA] is unique among commercially available products in that it does not contain unnecessary bacterial proteins, which may reduce immunogenicity,” Martina Kerscher, MD, PhD, of the University of Hamburg in Germany, and colleagues wrote.

The prospective, randomized, double-blind, dose-ranging, phase 2 study included 241 patients with moderate to severe glabellar frown lines (GFL) who were randomly assigned to receive 20, 50, 75 or 100 units of incobotulinumtoxinA.

Success was determined by at least 1 point improvement from baseline on the Facial Wrinkle Scale and duration of success increased with the increasing doses.

The 20-unit group had a median duration of success of 175 days, while the 50-unit group had a median duration of 185 days, the 75-unit group was a median of 210 days and the 100-unit group was a median duration of 215 days.

Adverse events or lack of efficacy did not lead any patients to discontinue treatment.

“These results demonstrate a clear [incobotulinumtoxinA] dose effect of at least 6 months duration for the majority of GFL subjects as assessed by 1-point improvement from baseline severity at maximum frown on the FWS,” the authors wrote. “There was a consistent prolongation in the median duration of effect with increasing doses.”