NT 201, a Botulinum Toxin Type A Preparation Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

This study has been completed.

First Received: February 1, 2007 Last Updated: November 27, 2008 History of Changes

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00430963

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. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will investigate the efficacy and safety 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 III

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Efficacy and Safety for NT 201, a Botulinum Toxin Type A Preparation Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Investigator's assessment
Patient's assessment

Enrollment:	256
Study Start Date:	October 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Conducted in Europe.

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: NCT00430963

Locations

Germany
Merz Pharmaceuticals GmbH
Frankfurt, Germany, 60318

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Chair:

Merz Pharmaceuticals

Merz Pharmaceuticals GmbH

More Information

No publications provided

Study ID Numbers:	MRZ 60201-0520/1
Study First Received:	February 1, 2007
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00430963 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Botulinum Toxins
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Botulinum Toxins
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009