Phase 2
N=399
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT03736928 ↗Enrolled (actual)
399
Serious AEs
1.3%
Results posted
Feb 2021
Primary outcome: Primary: Number of Composite Responders at Month 1 — 64; 71; 72; 77 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AbobotulinumtoxinA dose level 1 or 2 (Biological); placebo (Other); AbobotulinumtoxinA dose 3 (Biological); AbobotulinumtoxinA dose 4 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Composite Responders at Month 1 |
64; 71; 72; 77; 2 | — |
Summary
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
Eligibility Criteria
Inclusion Criteria
- Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
- Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
Exclusion Criteria
- Botulinum toxin treatment in the face within 9 months prior to study treatment
Data sourced from ClinicalTrials.gov (NCT03736928). 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.