Status:
COMPLETED
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
Lead Sponsor:
Revance Therapeutics, Inc.
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
Brief Summary
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT02303002
Start Date
December 1 2014
End Date
January 1 2016
Last Update
March 9 2016
Active Locations (1)
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1
Vancouver, British Columbia, Canada