NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Head2Head
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
2 other identifiers
interventional
381
3 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2008
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
February 10, 2012
CompletedMarch 8, 2012
March 1, 2012
5 months
October 21, 2008
January 23, 2012
March 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Responder by Independent Rater's Assessment at Maximum Frown at Week 4
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
4 weeks after injection
Secondary Outcomes (13)
Responder by Independent Rater's Assessment at Maximum Frown at Week 12
12 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 4
4 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 12
12 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 4
4 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 12
12 weeks after injection
- +8 more secondary outcomes
Study Arms (2)
IncobotulinumtoxinA (Xeomin®/Bocouture®)
EXPERIMENTALIncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.
OnabotulinumtoxinA (Vistabel®)
ACTIVE COMPARATOROnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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'.
You may not qualify if:
- Marked facial asymmetry.
- Ptosis of eyelid and/or eyebrow.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Baden, Austria
Unknown Facility
Krems, Austria
Unknown Facility
Salzburg, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Bad Soden, Germany
Unknown Facility
Böblingen, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Darmstadt, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Korschenbroich, Germany
Unknown Facility
Ludwigshafen, Germany
Unknown Facility
Munich, Germany
Unknown Facility
Wuppertal, Germany
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Suttion Coldfield, United Kingdom
Unknown Facility
Winchester, United Kingdom
Related Publications (1)
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.
PMID: 21134045RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthias Zerm
- Organization
- Merz Pharmaceuticals GmbH
Study Officials
- STUDY DIRECTOR
Medical Expert
Merz Pharmaceuticals GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
March 8, 2012
Results First Posted
February 10, 2012
Record last verified: 2012-03