Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines

The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.

Inclusion Criteria:

• Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest

Exclusion Criteria:

• Any previous treatment with any botulinum toxin
• Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
• Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
• Any history of facial surgery above the lower orbital rim
• Any planned facial surgery or aesthetic procedure during the study period
• Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period