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Dose Finding Study In Subjects With 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.
ClinicalTrials.gov Identifier: NCT01951742
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Investigators Global Assessment Scale [ Time Frame: Week 4 ]
    Crow's Feet Wrinkle Scale


Secondary Outcome Measures :
  1. Subject Self-Assessment score [ Time Frame: up to 12 12 weeks ]
    Subjects self assessment of severity of Crow's Feet



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 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

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): NCT01951742


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

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Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01951742     History of Changes
Other Study ID Numbers: ANT-1401-LCL-204
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Anterios Inc.:
wrinkles