Dose Finding Study In Subjects With Crow's Feet

May 20, 2014 updated by: Anterios Inc.

Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)

The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

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
    • Florida
      • Miami, Florida, United States, 33137
      • Pinellas Park, Florida, United States, 33781
      • West Palm Beach, Florida, United States, 33401
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Louisiana
      • Metairie, Louisiana, United States, 70006
      • New Orleans, Louisiana, United States, 70124
    • New York
      • Rochester, New York, United States, 14623
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
    • Virginia
      • Norfolk, Virginia, United States, 23507

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 at rest
  • moderate to severe Crow's Feet wrinkles 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

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
Placebo Comparator: Vehicle
vehicle without ANT-1401
Biological: Vehicle
Vehicle
Experimental: Dose 1
lowest dose
Biological: ANT-1401
Active
Experimental: Dose 2
second lowest dose
Biological: ANT-1401
Active
Experimental: Dose 3
mid-level dose
Biological: ANT-1401
Active
Experimental: Dose 4
second highest dose
Biological: ANT-1401
Active
Experimental: Dose 5
highest dose
Biological: ANT-1401
Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigators Global Assessment Scale
Time Frame: Week 4
Crow's Feet Wrinkle Scale
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Self-Assessment score
Time Frame: up to 12 12 weeks
Subjects self assessment of severity of Crow's Feet
up to 12 12 weeks

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

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 22, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANT-1401-LCL-204

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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