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Clinical Trials/NCT01776606
NCT01776606CompletedPhase 3

Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Revance Therapeutics, Inc.1 site in 1 country247 target enrollmentStarted: December 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
247
Locations
1
Primary Endpoint
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dose B

Placebo Comparator

Dose B: Placebo

Intervention: Placebo (Drug)

Dose A

Active Comparator

Dose A: Botulinum toxin type A

Intervention: Botulinum Toxin Type A (Drug)

Outcomes

Primary Outcomes

Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines

Time Frame: Week 4

Secondary Outcomes

  • Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment(Week 4)
  • Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment(Week 4)
  • Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment(Week 4)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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