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

Tracking Information

First Received Date ^ICMJE

June 2, 2008

Last Updated Date

February 13, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Investigator`s assessment [ Time Frame: 4 weeks after initial injection session ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00694148 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: NT 201

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

101

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00694148

Responsible Party

Central Medical Affairs, Merz Pharmaceuticals GmbH

Study ID Numbers ^ICMJE

MRZ 60201 GL_3001

Study Sponsor ^ICMJE

Merz Pharmaceuticals GmbH

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Matthias Imhof, MD

Ästhetische Dermatologie, Medico Palais Bad Soden

Information Provided By

Merz Pharmaceuticals GmbH

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP