Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Dose finding of NT 201 for glabellar frown lines
NCT00430586Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2006
- Countries
- 1
- Sponsor
- Merz
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- incobotulinumtoxinA
- Conditions
- glabellar rhytides
01
Overview
Phase 2, randomised, double-blind trial of incobotulinumtoxinA in glabellar rhytides (4 arms), sponsored by Merz. Primary endpoints: Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS) and Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale. Started Nov 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
10 U NT 201
10 Units of NT 201
20 U NT 201
20 Units of NT 201
30 U NT 201
30 Units of NT 201
Placebo
Placebo injection
03
Who it enrols
Adult patients with moderate to severe glabellar frown lines, excluding those with neuromuscular diseases or permanent implants in the area.
04
Endpoints
Primary
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
Secondary
Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Beyond the preview
Go deeper on NCT00430586.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00430586.