Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Phase 3
Completed
- Conditions
- Glabellar Frown Lines
- Registration Number
- NCT03960957
- Lead Sponsor
- Galderma R&D
- Brief Summary
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
Inclusion Criteria
- Moderate to severe glabellar lines at maximum frown
- Understands the study requirements and signs an informed consent form
Exclusion Criteria
- Botulinum toxin treatment in the face within 6 months prior to study treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo Month 1 after treatment Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of AbobotulinumtoxinA contribute to its efficacy in reducing glabellar lines?
How does the new dilution and injection volume of AbobotulinumtoxinA compare to standard botulinum toxin treatments in clinical trials?
Are there specific biomarkers that predict patient response to AbobotulinumtoxinA in facial line treatment?
What are the potential adverse events associated with the novel administration protocol of AbobotulinumtoxinA in NCT03960957?
How does AbobotulinumtoxinA's efficacy in treating glabellar lines compare to competitor neuromodulators like Botox or Dysport?
Trial Locations
- Locations (1)
Galderma Study Site
🇺🇸Spring, Texas, United States
Galderma Study Site🇺🇸Spring, Texas, United States