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

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ClinicalTrials.gov Identifier: NCT01809964
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : January 10, 2014
Sponsor:
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

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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
ANT-1401
Biological: ANT-1401
Experimental: Dose 2
ANT-1401
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

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01809964


Locations
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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.

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Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01809964     History of Changes
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