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OpenTrials
Completed

NCT Number: NCT02303002

Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines

This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

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Key information

Conditions

Glabellar Frown Lines

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate or severe glabellar frown lines
  • Female or male, 30 to 65 years of age in good general health
  • Women of childbearing potential must agree to use an effective method of birth control during the course of the study
  • Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

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 treatment area
  • Active skin disease or infections or irritation at the treatment area
  • Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
  • Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Treatment and study plan

Botulinum toxin type A

Biological

Intramuscular injection (IM)

Active Comparator botulinum toxin

Biological

IM injection

Placebo comparator

Biological

IM injection

Primary outcomes

  1. Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown

    Time frame: Week 24

  2. Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity

    Time frame: Up to Week 36

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Mar 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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