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OpenTrials
Completed

NCT Number: NCT02580370

Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal 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

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

  • In good general health
  • Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
  • Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion criteria

  • Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active skin disease or irritation or disrupted barrier at the treatment area
  • Active eye disease or irritation
  • Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
  • Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
  • Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
  • Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body

Treatment and study plan

Botulinum toxin type A

Biological

Topical botulinum toxin type A

Placebo comparator

Biological

Topical placebo comparator

Primary outcomes

  1. Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines

    Time frame: Week 4

Secondary outcomes

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

    Time frame: Week 4

    Proportion of subjects with 2 points 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

  4. Patient Severity Assessment with 1 points or greater improvement from baseline

    Time frame: Week 4

    Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Acronym: REALISE 1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Sep 9, 2016

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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