Dose Finding Study In Subjects With Crow's Feet

Phase 2

Completed

• Conditions: Lateral Canthal Lines; Crow's Feet

• Registration Number: NCT01951742
• Lead Sponsor: Anterios Inc.

Brief Summary

The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-22
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-05
• Disposition First Submitted: 2014-05-20
• Disposition First Submitted QC: 2014-05-20
• Last Update Submitted: 2014-05-20
• Disposition First Posted: 2014-05-29
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• 30 - 60 years of age
• mild to moderate Crow's Feet wrinkles at rest
• moderate to severe Crow's Feet wrinkles on contraction
• willingness to refrain from any product affecting skin remodeling
• female subjects must be not pregnant and non-lactating

Exclusion Criteria

• history of peri-ocular surgery, brow lift or related procedures
• procedures affecting the lateral canthal region in the prior 12 months
• application of topical prescription medication to the treatment area
• female subjects who are pregnant or are nursing a child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Investigators Global Assessment Scale	Week 4	Crow's Feet Wrinkle Scale

Secondary Outcome Measures

Name	Time	Method
Subject Self-Assessment score	up to 12 12 weeks	Subjects self assessment of severity of Crow's Feet