Skip to main content
OpenTrials
Completed

NCT Number: NCT01940991

Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Aging

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe crow's feet lines
  • Female or male, 18 to 65 years of age and in good general health
  • Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion criteria

  • Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active skin disease or irritation at the treatment area
  • Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
  • Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body

Treatment and study plan

Placebo

Drug

Placebo, Dose B; dose applied to the lateral canthal lines

Botulinum Toxin Type A

Drug

Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

Primary outcomes

  1. Composite endpoint

    Time frame: Week 4

    Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines

Secondary outcomes

  1. Investigator Global Assessment with 2 points or greater improvement from baseline

    Time frame: Week 4

    Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment

  2. Investigator Global Assessment with 1 point or greater improvement from baseline

    Time frame: Week 4

    Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment

  3. Patient Severity Assessment with 2 points or greater improvement from baseline

    Time frame: Week 4

    Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2013
Registry last updated
Jan 31, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.