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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01358695
First received: May 20, 2011
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Lateral Canthal Lines
Crow's Feet
Biological: ANT-1207
Biological: Botulinum Toxin, Type A
Biological: Botulinum Toxin Type A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines

Resource links provided by NLM:


Further study details as provided by Anterios Inc.:

Primary Outcome Measures:
  • Efficacy will be assessed by Investigator's Global Assessment Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Wrinkle scale with definitions of severity


Secondary Outcome Measures:
  • Subject Self Assessment (SSA) scale [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Change from Baseline in the Subject Self Assessment scale

  • Investigator Global Assessment scale [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
    Change from Baseline in wrinkle scale assessment at all other timepoints


Enrollment: 111
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358695

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

No publications provided

Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01358695     History of Changes
Other Study ID Numbers: ANT-1207-201-LCL
Study First Received: May 20, 2011
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Anterios Inc.:
Lateral Canthal Lines
Crow's Feet

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014