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

This study has been completed.

First Received: June 2, 2008 Last Updated: February 13, 2009 History of Changes

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00694148

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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 ]

Estimated Enrollment:	101
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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694148

Locations

Germany, Hessen
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

No publications provided

Responsible Party:	Merz Pharmaceuticals GmbH ( Central Medical Affairs )
Study ID Numbers:	MRZ 60201 GL_3001
Study First Received:	June 2, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00694148 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merz Pharmaceuticals GmbH:

Treatment of glabellar frown lines

Study placed in the following topic categories:

Botulinum Toxins
Peripheral Nervous System Agents
Healthy
Botulinum Toxin Type A

Additional relevant MeSH terms:

Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Botulinum Toxin Type A
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009