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

Phase 3

Completed

• Conditions: Healthy

• Registration Number: NCT00694148
• Lead Sponsor: Merz Pharmaceuticals GmbH

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

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Investigator's assessment	4 weeks after initial injection session

Trial Locations

Locations (1)

Dr. Matthias Imhof, Medico Palais Bad Soden; 🇩🇪 Bad Soden, Hessen, Germany