Status:
COMPLETED
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Moderate to Severe Glabellar Frown Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study objective is 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...
Detailed Description
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 fro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT00770211
Start Date
October 1 2008
End Date
June 1 2009
Last Update
October 7 2011
Active Locations (8)
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1
About Skin Dermatoloy
Englewood, Colorado, United States, 80113
2
Center for Cosmetic Enhancement
Aventura, Florida, United States, 33180
3
Frederic Brandt
Coral Gables, Florida, United States, 33146
4
Advanced Dermatology Research Institute
Lincolnshire, Illinois, United States, 60069