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Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694148
First Posted: June 10, 2008
Last Update Posted: October 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
  Purpose
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Investigator`s assessment [ Time Frame: 4 weeks after initial injection session ]

Enrollment: 108
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NT 201

    A Botulinum neurotoxin type A, free of complexing proteins

    Detailed described in study protocol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694148


Locations
Germany
Dr. Matthias Imhof, Medico Palais Bad Soden
Bad Soden, Hessen, Germany, 65812
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: Matthias Imhof, MD Ästhetische Dermatologie, Medico Palais Bad Soden
  More Information

Publications:
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00694148     History of Changes
Other Study ID Numbers: MRZ 60201 GL_3001
2008-000549-73 ( EudraCT Number )
First Submitted: June 2, 2008
First Posted: June 10, 2008
Last Update Posted: October 30, 2012
Last Verified: October 2012

Keywords provided by Merz Pharmaceuticals GmbH:
Treatment of glabellar frown lines

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents