COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Clinical Trial to Evaluate ANT-1401 in Crow's Feet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809964
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : January 10, 2014
Information provided by (Responsible Party):
Anterios Inc.

Brief Summary:
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Crows Feet Biological: ANT-1401 Biological: Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Dose 1
Biological: ANT-1401
Experimental: Dose 2
Biological: ANT-1401
Placebo Comparator: Vehicle
Placebo Vehicle
Biological: Vehicle

Primary Outcome Measures :
  1. Investigator's Global Assessment Scale [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Subject Self-Assessment [ Time Frame: Week 4 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 30 - 60 years of age
  • mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
  • moderate to severe Crow's Feet (IGA 2-3) on contraction
  • moderate to severe Crow's Feet (SSA 2-3) on contraction
  • Have adequate vision to assess facial wrinkles in a mirror

Exclusion Criteria:

  • botulinum toxin treatment in the prior 6 months
  • history of periocular surgery, brow lift or related procedures
  • soft tissue augmentation in the lateral canthal region in the prior 12 months
  • dermabrasion or laser treatment in the periocular region in the last 6 months
  • topical prescription-strength retinoids in the prior 3 months
  • present or history of neuromuscular disease
  • present or history of "dry eye"
  • systemic aminoglycoside use in the week prior to treatment application

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809964

Layout table for location information
United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Florida
Miami, Florida, United States, 33137
Pinellas Park, Florida, United States, 33781
West Palm Beach, Florida, United States, 33401
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Tennessee
Knoxville, Tennessee, United States, 37922
Sponsors and Collaborators
Anterios Inc.
Layout table for additonal information
Responsible Party: Anterios Inc. Identifier: NCT01809964    
Other Study ID Numbers: ANT-1401-LCL-203
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: December 2013