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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00694148
First received: June 2, 2008
Last updated: October 29, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Study First Received: June 2, 2008
Last Updated: October 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014