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

Phase 2

Completed

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

• Registration Number: NCT01940991
• Lead Sponsor: Revance Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Disposition First Submitted: 2013-12-27
• Disposition First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Disposition First Posted: 2014-01-31
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment with 2 points or greater improvement from baseline	Week 4	Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment
Investigator Global Assessment with 1 point or greater improvement from baseline	Week 4	Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment
Patient Severity Assessment with 2 points or greater improvement from baseline	Week 4	Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment

Trial Locations

Locations (1)

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