Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02303002
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 25, 2014
First Posted Date  ICMJE November 27, 2014
Last Update Posted Date March 9, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
  • Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown [ Time Frame: Week 24 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
Official Title  ICMJE Not Provided
Brief Summary This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glabellar Frown Lines
Intervention  ICMJE
  • Biological: Botulinum Toxin Type A
    Intramuscular injection (IM)
  • Biological: Active Comparator botulinum toxin
    IM injection
  • Biological: Placebo Comparator
    IM injection
Study Arms  ICMJE
  • Experimental: Dose A
    Dose A: Botulinum Toxin Type A
    Intervention: Biological: Botulinum Toxin Type A
  • Experimental: Dose B
    Dose B: Botulinum Toxin Type A
    Intervention: Biological: Botulinum Toxin Type A
  • Experimental: Dose C
    Dose C: Botulinum Toxin Type A
    Intervention: Biological: Botulinum Toxin Type A
  • Active Comparator: Dose D
    Dose D: Botulinum Toxin Type A
    Intervention: Biological: Active Comparator botulinum toxin
  • Placebo Comparator: Dose E
    Dose E: Placebo
    Intervention: Biological: Placebo Comparator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
268
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2014)
250
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02303002
Other Study ID Numbers  ICMJE RT002-CL002
CTA Control No. 179120 ( Other Identifier: Health Canada )
File No. 9427-R1312\1-22C ( Other Identifier: Health Canada )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Revance Therapeutics, Inc.
Study Sponsor  ICMJE Revance Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Revance Therapeutics, Inc.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP