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 enrollmentDecember 2012

ConditionsSkin Aging

InterventionsPlacebo Botulinum Toxin Type A

DrugsBotulinum Toxin Type A Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Skin Aging
Sponsor: Revance Therapeutics, Inc.
Enrollment: 247
Locations: 1
Primary Endpoint: Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

May 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Revance Therapeutics, Inc.

Responsible Party

Sponsor

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

Arms & Interventions

Dose B

Dose B: Placebo

Intervention: Placebo

Dose A

Dose A: Botulinum toxin type A

Intervention: Botulinum Toxin Type A

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)