Phase 3
N=271
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Moderate to Severe Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT00770211 ↗Enrolled (actual)
271
Serious AEs
0.4%
Results posted
Sep 2011
Primary outcome: Primary: Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale — 87; 0 Particpants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IncobotulinumtoxinA (Xeomin) (20 Units) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale |
87; 0 | <0.0001 sig |
| SECONDARY Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS) |
157; 50 | — |
| SECONDARY 1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale |
137; 13 | — |
| SECONDARY Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS |
139; 0 | — |
| SECONDARY 1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale |
152; 10 | — |
Summary
The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.
Eligibility Criteria
Inclusion Criteria
- Age 18 or over
- Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by investigator's rating: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
- Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by patient's assessment: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
- Stable medical condition
Exclusion Criteria
- Previous treatment with Botulinum toxin of any serotype in the glabellar area within the last 8 month
- Previous treatment with any facial aesthetic procedure (e.g. injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 month
- Previous insertion of permanent material in the glabellar area (regardless of the time between previous treatment and this study)
- Planned treatment with Botulinum toxin of any serotype in any other body region during the study period
- 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 and the surrounding areas (including eye brow)
- Any other planned facial aesthetic procedure 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
Data sourced from ClinicalTrials.gov (NCT00770211). 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.