IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines No. 2

Summary

The study objective was to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines to be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.

Timeline

Start

2008-10

Primary completion

2009-03

Completion

2009-06

Outcome

Met primary endpoint

registry IncobotulinumtoxinA (Xeomin) (20 Units) vs Placebo; p <0.0001; Difference response rate 0.60 (95% CI 0.52 to 0.68); Fisher Exact NCT00770029 ↗

Publications

• Results Carruthers A, Carruthers J, Coleman WP 3rd, Donofrio L, Flynn T, Gold M, Heinz M, Harrington L, Jones D, McDaniel D, Rohrer T, Schlobe A, Solish N, Weiss RA. Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg. 2013 Apr;39(4):551-8. doi: 10.1111/dsu.12100. Epub 2013 Feb 4.

Drugs

Indications

No indication recorded.