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

Launched by MERZ PHARMACEUTICALS GMBH · Oct 8, 2008

Keywords

ClinConnect Summary

The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximately 255 subjects into one treatment and one placebo group at a ratio of 2 : 1. After the single injection treatment with a total dose of 20 Units IncobotulinumtoxinA (Xeomin) or corresponding placebo, the subjects were observed over 120 days. During the study participation the ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 or over
• • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by investigator's rating: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe'
• • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by patient's assessment: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe'
• • Stable medical condition
• Exclusion Criteria:
• • Previous treatment with Botulinum toxin of any serotype in the glabellar area within the last 8 month
• • Previous treatment with any facial aesthetic procedure (e.g. injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 month
• • Previous insertion of permanent material in the glabellar area (regardless of the time between previous treatment and this study)
• • Planned treatment with Botulinum toxin of any serotype in any other body region during the study period
• • 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 and the surrounding areas (including eye brow)
• • Any other planned facial aesthetic procedure 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