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

December 10, 2013 updated by: Anterios Inc.

Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • Florida
      • Miami, Florida, United States, 33137
      • Pinellas Park, Florida, United States, 33781
      • West Palm Beach, Florida, United States, 33401
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Tennessee
      • Knoxville, Tennessee, United States, 37922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator's Global Assessment Scale
Time Frame: Week 4
Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject Self-Assessment
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterios Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ANT-1401-LCL-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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