Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
This study has been completed.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
First received: June 2, 2008
Last updated: October 29, 2012
Last verified: October 2012
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.
Drug: NT 201
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Investigator`s assessment [ Time Frame: 4 weeks after initial injection session ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694148
|Dr. Matthias Imhof, Medico Palais Bad Soden
|Bad Soden, Hessen, Germany, 65812 |
Merz Pharmaceuticals GmbH
||Matthias Imhof, MD
||Ästhetische Dermatologie, Medico Palais Bad Soden
||Merz Pharmaceuticals GmbH
History of Changes
|Other Study ID Numbers:
||MRZ 60201 GL_3001, 2008-000549-73
|Study First Received:
||June 2, 2008
||October 29, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Merz Pharmaceuticals GmbH:
ClinicalTrials.gov processed this record on March 26, 2015
Treatment of glabellar frown lines