CompletedInterventionalPhase 3Updated Mar 19, 2025
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines | NCT02303002 | Trialant
CompletedInterventionalPhase 2Updated Mar 9, 2016
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
ClinicalTrials.gov ID
NCT02303002
Lead Sponsor
Revance Therapeutics, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
268Actual
Last Update Posted
Mar 9, 2016Estimated
Start Date
Dec 2014
Primary Completion Date
Dec 2015Actual
Completion Date
Jan 2016Actual
Brief Summary
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
Glabellar Frown Lines
Botulinum Toxin Type A
Active Comparator botulinum toxin
Placebo Comparator
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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