Status:
COMPLETED
Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 wide...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00694148
Start Date
May 1 2008
End Date
January 1 2009
Last Update
October 30 2012
Active Locations (1)
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1
Dr. Matthias Imhof, Medico Palais Bad Soden
Bad Soden, Hesse, Germany, 65812