Phase 3
N=381
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT00777803 ↗Enrolled (actual)
381
Serious AEs
0.5%
Results posted
Feb 2012
Primary outcome: Primary: Responder by Independent Rater's Assessment at Maximum Frown at Week 4 — 267; 89 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) (Drug); OnabotulinumtoxinA (Vistabel®) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder by Independent Rater's Assessment at Maximum Frown at Week 4 |
267; 89 | — |
| SECONDARY Responder by Independent Rater's Assessment at Maximum Frown at Week 12 |
222; 73 | — |
| SECONDARY Responder by Independent Rater's Assessment at Rest at Week 4 |
115; 37 | — |
| SECONDARY Responder by Independent Rater's Assessment at Rest at Week 12 |
100; 33 | — |
| SECONDARY Responder by Investigator's Assessment at Maximum Frown at Week 4 |
274; 89 | — |
| SECONDARY Responder by Investigator's Assessment at Maximum Frown at Week 12 |
220; 76 | — |
| SECONDARY Responder by Investigator's Assessment at Rest at Week 4 |
210; 66 | — |
| SECONDARY Responder by Investigator's Assessment at Rest at Week 12 |
166; 51 | — |
| SECONDARY Responder by Patient's Assessment at Maximum Frown at Week 4 |
260; 87 | — |
| SECONDARY Responder by Patient's Assessment at Maximum Frown at Week 12 |
202; 71 | — |
| SECONDARY Responder by Patient's Assessment at Rest at Week 4 |
193; 70 | — |
| SECONDARY Response by Patient's Assessment at Rest at Week 12 |
152; 53 | — |
| SECONDARY Responder by Patient's Global Assessment at Week 4 |
259; 86 | — |
| SECONDARY Responder by Patient's Global Assessment at Week 12 |
229; 75 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00777803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.