Overview
Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Status:
Completed
Completed
Trial end date:
2009-01-01
2009-01-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Merz Pharmaceuticals GmbHTreatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
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