Trial record 3 of 81 for:    1401

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01809964
First received: March 7, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Lateral Canthal Lines
Crows Feet
Biological: ANT-1401
Biological: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines

Resource links provided by NLM:


Further study details as provided by Anterios Inc.:

Primary Outcome Measures:
  • Investigator's Global Assessment Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Self-Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: March 2013
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
ANT-1401
Biological: ANT-1401
Experimental: Dose 2
ANT-1401
Biological: ANT-1401
Placebo Comparator: Vehicle
Placebo Vehicle
Biological: Vehicle

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809964

Locations
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.
  More Information

No publications provided

Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01809964     History of Changes
Other Study ID Numbers: ANT-1401-LCL-203
Study First Received: March 7, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 20, 2014