Clinical trial NCT00777803: NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 381
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Main Inclusion Criteria:

• Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'.

Main Exclusion Criteria:

* Marked facial asymmetry.
* Ptosis of eyelid and/or eyebrow.

Primary outcomes:
measure: Responder by Independent Rater's Assessment at Maximum Frown at Week 4
timeFrame: 4 weeks after injection
Secondary outcomes:
measure: Responder by Independent Rater's Assessment at Maximum Frown at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Independent Rater's Assessment at Rest at Week 4
timeFrame: 4 weeks after injection
measure: Responder by Independent Rater's Assessment at Rest at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Investigator's Assessment at Maximum Frown at Week 4
timeFrame: 4 weeks after injection
measure: Responder by Investigator's Assessment at Maximum Frown at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Investigator's Assessment at Rest at Week 4
timeFrame: 4 weeks after injection
measure: Responder by Investigator's Assessment at Rest at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Patient's Assessment at Maximum Frown at Week 4
timeFrame: 4 weeks after injection
measure: Responder by Patient's Assessment at Maximum Frown at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Patient's Assessment at Rest at Week 4
timeFrame: 4 weeks after injection
measure: Response by Patient's Assessment at Rest at Week 12
timeFrame: 12 weeks after injection
measure: Responder by Patient's Global Assessment at Week 4
timeFrame: 4 weeks after injection
measure: Responder by Patient's Global Assessment at Week 12
timeFrame: 12 weeks after injection
Other outcomes:
Locations:
city: Baden
country: Austria
city: Krems
country: Austria
city: Salzburg
country: Austria
city: Vienna
country: Austria
city: Bad Soden
country: Germany
city: Boeblingen
country: Germany
city: Cologne
country: Germany
city: Darmstadt
country: Germany
city: Frankfurt
country: Germany
city: Korschenbroich
country: Germany
city: Ludwigshafen
country: Germany
city: Munich
country: Germany
city: Wuppertal
country: Germany
city: Glasgow
country: United Kingdom
city: Manchester
country: United Kingdom
city: Suttion Coldfield
country: United Kingdom
city: Winchester
country: United Kingdom
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.