NCT00777803

NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))	NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
DRUG	OnabotulinumtoxinA (Vistabel®)	OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-10-22
• Last updated: 2012-03-08
• Results posted: 2012-02-10

Locations

17 sites across 3 countries: Austria, Germany, United Kingdom