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Trial record 16 of 737 for:    Botulinum Toxins, Type A

Clinical Trial To Evaluate ANT-1207 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: NCT01358695
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.

Brief Summary:
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Crow's Feet Biological: ANT-1207 Biological: Botulinum Toxin, Type A Biological: Botulinum Toxin Type A Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines
Study Start Date : May 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator Biological: ANT-1207
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Experimental: Dose 1
Dose 1
Biological: ANT-1207
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Experimental: Dose 2
Dose 2
Biological: ANT-1207
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Experimental: Dose 3
Dose 3
Biological: ANT-1207
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Experimental: Dose 4
Dose 4
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Experimental: Dose 5
Dose 5
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.

Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.




Primary Outcome Measures :
  1. Efficacy will be assessed by Investigator's Global Assessment Score [ Time Frame: 2 weeks ]
    Wrinkle scale with definitions of severity


Secondary Outcome Measures :
  1. Subject Self Assessment (SSA) scale [ Time Frame: 2 Weeks ]
    Change from Baseline in the Subject Self Assessment scale

  2. Investigator Global Assessment scale [ Time Frame: Week 1, 2, 4, 8, 12 ]
    Change from Baseline in wrinkle scale assessment at all other timepoints



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
  • moderate to severe Crow's Feet (IGA 3-4) 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): NCT01358695


Locations
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United States, Alabama
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, Florida
Baumann Cosmetic & Research Institute
Miami Beach, Florida, United States, 33140
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, United States, 33401
United States, Louisiana
William Coleman III, MD, APMC
Metairie, Louisiana, United States, 70006
United States, New York
Gramercy Park Dermatology
New York, New York, United States, 10010
United States, North Carolina
Cary Skin Care
Cary, North Carolina, United States, 27519
Sponsors and Collaborators
Anterios Inc.

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Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01358695     History of Changes
Other Study ID Numbers: ANT-1207-201-LCL
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by Anterios Inc.:
Lateral Canthal Lines
Crow's Feet

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents