Glabellar Frown Lines
Conditions
Brief summary
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
Interventions
BIOLOGICALBotulinum Toxin Type A
Intramuscular injection (IM)
BIOLOGICALActive Comparator botulinum toxin
IM injection
BIOLOGICALPlacebo Comparator
IM injection
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Moderate or severe glabellar frown lines * Female or male, 30 to 65 years of age in good general health * Women of childbearing potential must agree to use an effective method of birth control during the course of the study * Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response
Exclusion criteria
* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis * Muscle weakness or paralysis, particularly in the treatment area * Active skin disease or infections or irritation at the treatment area * Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart * Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown | Week 24 |
| Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity | Up to Week 36 |
Countries
Canada
Outcome results
None listed