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Finding of Optimal Dose for NT 201, a Botulinum Toxin Type A Preparation Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
This study has been completed.
Sponsored by: Merz Pharmaceuticals GmbH
Information provided by: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00430586
  Purpose

NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.


Condition Intervention Phase
Glabellar Frown Lines
Drug: Botulinum neurotoxin type A, free of complexing proteins
Phase II

MedlinePlus related topics: Botox
Drug Information available for: Clostridium botulinum toxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by Merz Pharmaceuticals GmbH:

Study Start Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430586

Locations
Germany
Merz Pharmaceuticals GmbH
Frankfurt, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Merz Pharmaceuticals Merz Pharmaceuticals GmbH
  More Information

Study ID Numbers: MRZ 60201-0527/1
Study First Received: February 1, 2007
Last Updated: February 6, 2008
ClinicalTrials.gov Identifier: NCT00430586  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Botulinum Toxins
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on January 14, 2009