Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines
Completed · Phase 3
Conditions studied: Glabellar Lines
In brief
The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.
Key facts
- Study ID
- NCT00512135
- Run by
- Merz Pharmaceuticals GmbH
- People needed
- 801
- Starts
- 2007-06-18
- Expected to finish
- 2009-12-28
- Last updated by the study team
- 2021-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program
You may not qualify if…
- Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.
Where it is running
- Skin Care Centre — Los Angeles, California, United States
- About Skin Dermatology — Englewood, Colorado, United States
- Centre for Cosmetic Enhancement — Aventura, Florida, United States
- Brandt — Coral Gables, Florida, United States
- Advanced Dermatology Research Institute — Lincolnshire, Illinois, United States
- Laser &Skin Surgery Center of Indiana — Carmel, Indiana, United States
- Coleman — Metairie, Louisiana, United States
- Skin Care Physisians of Chestnut Hill — Chestnut Hill, Massachusetts, United States
- Schlessinger — Omaha, Nebraska, United States
- Image Dermatology P.C. — Montclair, New Jersey, United States
- Narins — White Plains, New York, United States
- Flynn Consulting PLLC — Raleigh, North Carolina, United States
- Tennessee Clinical Research Center — Nashville, Tennessee, United States
- Carruthers Dermatology Centre Inc. — Vancouver, British Columbia, Canada
- Solish — Toronto, Ontario, Canada
- Charité Berlin - Klinik für Dermatologie — Berlin, Germany
- Rosenparkklinik — Darmstadt, Germany
- Krankenhaus Dresden Friedrichstadt — Dresden, Germany
- Johann-Wolfgang-Goethe- Universitätsklinikum Frankfurt — Frankfurt am Main, Germany
- Universität Hamburg — Hamburg, Germany
- SCIderm GmbH — Hamburg, Germany
- Uniklinik Saarland — Homburg / Saar, Germany
- Dr. Michael Sebastian — Mahlow, Germany
- Dr. Hans-Ulrich Voigt — München, Germany
- Dr. Thomas Dirschka — Wuppertal, Germany
Full record on ClinicalTrials.gov
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