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Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe 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: NCT03014622
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE December 8, 2016
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Proportion of subjects who achieve the following status concurrently at Week 4: A score of 0 or 1 (i.e. none or mild wrinkles in severity) on both IGA-FWS and PFWS assessments; At least 2 pt improvement from baseline on both IGA-FWS and PFWS assessments [ Time Frame: Week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03014622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Proportion of subjects who achieve a score of ≥ 1 on the investigator's assessment of GAIS [ Time Frame: From Week 2 to Week 24 ]
  • Proportion of subjects who achieve a score of ≥ 1 on the subject's self-assessment of GAIS [ Time Frame: From Week 2 to Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
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 DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)
Brief Summary This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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 Toxins, Type A
    Intramuscular injection
    Other Name: DaxibotulinumtoxinA
  • Biological: Placebos
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: DaxibotulinumtoxinA 40 units
    Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
    Intervention: Biological: Botulinum Toxins, Type A
  • Placebo Comparator: Placebo
    Biological/Vaccine: Placebos Intramuscular injection
    Intervention: Biological: Placebos
Publications * Not Provided

*   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: December 4, 2017)
303
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
300
Actual Study Completion Date  ICMJE November 14, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide written informed consent including authorization to release health information
  • Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
  • Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
  • Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

  • Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
  • Active skin disease, infections or inflammation at the injection sites
  • Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
  • History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
  • Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014622
Other Study ID Numbers  ICMJE 1620301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 September 2019

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