Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.

NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.

Inclusion Criteria:

• moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
• Stable medical condition
• Age: between 18 and 65 years (inclusively)

Exclusion Criteria:

• Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
• Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
• Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
• Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
• Any other planned cosmetic procedure in the upper third part of the face during the trial period
• Inability to substantially lessen glabellar frown lines even by physically spreading them apart
• Marked facial asymmetry or ptosis of eyelid and/or eyebrow
• History of facial nerve palsy
• Any infection in the area of the injection sites