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

NCT00694148 | Completed Phase 3

• 2 other identifiers: MRZ 60201 GL_30012008-000549-73
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Treatment of glabellar frown lines

Outcome Measures

Primary Outcomes (1)

• Investigator's assessment

  4 weeks after initial injection session

Interventions

NT 201 DRUG

A Botulinum neurotoxin type A, free of complexing proteins Detailed described in study protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Dr. Matthias Imhof, Medico Palais Bad Soden

Bad Soden, Hesse, 65812, Germany

Location

Related Publications (1)

• Imhof M, Kuhne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.

  PMID: 22010053 RESULT

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Matthias Imhof, MD

  Ästhetische Dermatologie, Medico Palais Bad Soden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 10, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

DE (1)