Skip to main content
OpenTrials
Completed

NCT Number: NCT00694148

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Matthias Imhof, Medico Palais Bad Soden

Bad Soden, Hesse, 65812, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NT 201

Drug

A Botulinum neurotoxin type A, free of complexing proteins

Detailed described in study protocol

Primary outcomes

  1. Investigator's assessment

    Time frame: 4 weeks after initial injection session

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2008
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.