Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet

Phase 2

Completed

• Conditions: Lateral Canthal Lines; Crow's Feet
• Interventions: Biological: ANT-1207; Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A

• Registration Number: NCT01358695
• Lead Sponsor: Anterios Inc.

Brief Summary

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2013-06
• Disposition First Submitted: 2013-06-21
• Disposition First Submitted QC: 2013-06-21
• Last Update Submitted: 2013-06-21
• Disposition First Posted: 2013-07-01
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
• moderate to severe Crow's Feet (IGA 3-4) 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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dose 2	Botulinum Toxin Type A	Dose 2
Dose 3	ANT-1207	Dose 3
Dose 1	Botulinum Toxin Type A	Dose 1
Dose 2	ANT-1207	Dose 2
Dose 2	Botulinum Toxin, Type A	Dose 2
Placebo Comparator	ANT-1207	-
Placebo Comparator	Botulinum Toxin Type A	-
Dose 1	ANT-1207	Dose 1
Dose 1	Botulinum Toxin, Type A	Dose 1
Dose 3	Botulinum Toxin, Type A	Dose 3
Dose 3	Botulinum Toxin Type A	Dose 3
Dose 4	Botulinum Toxin, Type A	Dose 4
Dose 4	Botulinum Toxin Type A	Dose 4
Dose 5	Botulinum Toxin, Type A	Dose 5
Dose 5	Botulinum Toxin Type A	Dose 5

Primary Outcome Measures

Name	Time	Method
Efficacy will be assessed by Investigator's Global Assessment Score	2 weeks	Wrinkle scale with definitions of severity

Secondary Outcome Measures

Name	Time	Method
Subject Self Assessment (SSA) scale	2 Weeks	Change from Baseline in the Subject Self Assessment scale
Investigator Global Assessment scale	Week 1, 2, 4, 8, 12	Change from Baseline in wrinkle scale assessment at all other timepoints

Trial Locations

Locations (6)

Total Skin & Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Palm Beach Esthetic Dermatology and Laser Center; 🇺🇸 West Palm Beach, Florida, United States

Baumann Cosmetic & Research Institute; 🇺🇸 Miami Beach, Florida, United States

William Coleman III, MD, APMC; 🇺🇸 Metairie, Louisiana, United States

Gramercy Park Dermatology; 🇺🇸 New York, New York, United States

Cary Skin Care; 🇺🇸 Cary, North Carolina, United States