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Completed

NCT Number: NCT01358695

Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet

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.

Completed

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Key information

Conditions

Lateral Canthal Lines Crow's Feet

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Total Skin & Beauty Dermatology Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANT-1207

Biological

The interventions differ by dose of investigational product applied.

Botulinum Toxin, Type A

Biological

The interventions differ by dose of investigational product applied.

Botulinum toxin type A

Biological

The interventions differ by dose of investigational product applied.

Primary outcomes

  1. Efficacy will be assessed by Investigator's Global Assessment Score

    Time frame: 2 weeks

    Wrinkle scale with definitions of severity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Anterios Inc.

Industry

Registry information

Official study title

Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 24, 2011
Registry last updated
Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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