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

Phase 3

Completed

• Conditions: Skin Aging
• Interventions: Drug: Botulinum Toxin Type A; Drug: Placebo

• Registration Number: NCT01776606
• Lead Sponsor: Revance Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2013-08-09
• Disposition First Submitted QC: 2013-08-19
• Disposition First Posted: 2013-08-27
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose A	Botulinum Toxin Type A	Dose A: Botulinum toxin type A
Dose B	Placebo	Dose B: Placebo

Primary Outcome Measures

Name	Time	Method
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines	Week 4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dermatology Research Institute; 🇺🇸 Coral Gables, Florida, United States