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Completed

NCT Number: NCT01809964

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

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

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Key information

Conditions

Lateral Canthal Lines Crows Feet

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ANT-1401

Biological

Vehicle

Biological

Primary outcomes

  1. Investigator's Global Assessment Scale

    Time frame: Week 4

Secondary outcomes

  1. Subject Self-Assessment

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Anterios Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
Jan 10, 2014

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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