Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines | NCT01940991 | Trialant
CompletedInterventionalPhase 2Updated Jan 31, 2014
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
ClinicalTrials.gov ID
NCT01940991
Lead Sponsor
Revance Therapeutics, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
82Actual
Last Update Posted
Jan 31, 2014Estimated
Start Date
Aug 2013
Primary Completion Date
Nov 2013Actual
Completion Date
Nov 2013Actual
Brief Summary
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines
Skin Aging
Placebo
Botulinum Toxin Type A
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe crow's feet lines
Female or male, 18 to 65 years of age and in good general health
Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study
Exclusion Criteria:
Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
Muscle weakness or paralysis, particularly in the area receiving study treatment
Active skin disease or irritation at the treatment area
Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body