Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Status and phase
Completed
Phase 2
Conditions
Glabellar Frown Lines
Treatments
Other: placebo
Biological: AbobotulinumtoxinA dose 3
Biological: AbobotulinumtoxinA dose 4
Biological: AbobotulinumtoxinA dose level 1 or 2
Details and patient eligibility
About
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
Enrollment
401 patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Double Blind
401 participants in 4 patient groups, including a placebo group
Placebo
Placebo Comparator group
Description:
Intramuscular single treatment
Treatment:
Other: placebo
AbobotulinumtoxinA dose level 1 or 2
Experimental group
Description:
Intramuscular single treatment
Treatment:
Biological: AbobotulinumtoxinA dose level 1 or 2
AbobotulinumtoxinA dose level 3
Experimental group
Description:
Intramuscular single treatment
Treatment:
Biological: AbobotulinumtoxinA dose 3
AbobotulinumtoxinA dose level 4
Experimental group
Description:
Intramuscular single treatment
Treatment:
Biological: AbobotulinumtoxinA dose 4
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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