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Completed

NCT Number: NCT01776606

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

This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

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Key information

Conditions

Skin Aging

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Week 4

Secondary outcomes

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

    Time frame: Week 4

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

    Time frame: Week 4

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

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Acronym: RADIANT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
May 7, 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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