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Sponsored by: |
Merz Pharmaceuticals GmbH |
---|---|
Information provided by: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00694148 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: NT 201 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 101 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
A Botulinum neurotoxin type A, free of complexing proteins
Detailed described in study protocol
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Hessen | |
Dr. Matthias Imhof, Medico Palais Bad Soden | |
Bad Soden, Hessen, Germany, 65812 |
Principal Investigator: | Matthias Imhof, MD | Ästhetische Dermatologie, Medico Palais Bad Soden |
Responsible Party: | Merz Pharmaceuticals GmbH ( Central Medical Affairs ) |
Study ID Numbers: | MRZ 60201 GL_3001 |
Study First Received: | June 2, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00694148 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Treatment of glabellar frown lines |
Botulinum Toxins Healthy Botulinum Toxin Type A |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |