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

Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines

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.

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines; Crow's Feet
• Intervention / Treatment: Biological: ANT-1207; Biological: Botulinum Toxin Type A; Biological: Botulinum Toxin, Type A

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin & Beauty Dermatology Center
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Baumann Cosmetic & Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Palm Beach Esthetic Dermatology and Laser Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • William Coleman III, MD, APMC
  • New York
    • New York, New York, United States, 10010
      • Gramercy Park Dermatology
  • North Carolina
    • Cary, North Carolina, United States, 27519
      • Cary Skin Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Biological: ANT-1207; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.
Experimental: Dose 1	Biological: ANT-1207; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin, Type A; The interventions differ by dose of investigational product applied.
Experimental: Dose 2	Biological: ANT-1207; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin, Type A; The interventions differ by dose of investigational product applied.
Experimental: Dose 3	Biological: ANT-1207; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin, Type A; The interventions differ by dose of investigational product applied.
Experimental: Dose 4	Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin, Type A; The interventions differ by dose of investigational product applied.
Experimental: Dose 5	Biological: Botulinum Toxin Type A; The interventions differ by dose of investigational product applied.; Biological: Botulinum Toxin, Type A; The interventions differ by dose of investigational product applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy will be assessed by Investigator's Global Assessment Score	Wrinkle scale with definitions of severity	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anterios Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Lateral Canthal Lines; Crow's Feet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: ANT-1207-201-LCL