Phase 2
N=80
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Platysmal Bands
Bottom Line
View on ClinicalTrials.gov: NCT04080882 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo — 3; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AbobotulinumtoxinA dose 1 (Biological); Placebo (Other); AbobotulinumtoxinA dose 2 (Biological); AbobotulinumtoxinA dose 3 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo |
3; 36 | — |
Summary
Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale
- Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale
Exclusion Criteria
- Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment
Data sourced from ClinicalTrials.gov (NCT04080882). 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.