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Trial record 2 of 888 for:    DaxibotulinumtoxinA for Injection
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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
Results First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Study Description
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Brief Summary:
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: Botulinum Toxins, Type A Biological: Placebos Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 8, 2016
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: DaxibotulinumtoxinA 40 units
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
 Biological: Botulinum Toxins, Type A
Intramuscular injection
Other Name: DaxibotulinumtoxinA
Placebo Comparator: Placebo
Biological/Vaccine: Placebos Intramuscular injection
 Biological: Placebos
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales [ Time Frame: Week 4 ]
    Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments


Secondary Outcome Measures :
  1. The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group [ Time Frame: 0-36 weeks ]
    The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.

  2. The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group [ Time Frame: 0-36 weeks ]
    The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014622


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
United States, California
Beverly Hills, California, United States, 90210
Newport Beach, California, United States, 92663
San Francisco, California, United States, 94117
Santa Monica, California, United States, 90404
United States, Colorado
Greenwood, Colorado, United States, 80111
United States, Florida
Boca Raton, Florida, United States, 33431
Coral Gables, Florida, United States, 33146
United States, Massachusetts
Chestnut Hill, Massachusetts, United States, 02467
United States, Michigan
Birmingham, Michigan, United States, 48009
United States, New Jersey
Montclair, New Jersey, United States, 07042
United States, New York
New York, New York, United States, 10001
New York, New York, United States, 10022
United States, North Carolina
Chapel Hill, North Carolina, United States, 27517
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Revance Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Revance Therapeutics, Inc.:
Study Protocol  [PDF] November 7, 2016
Statistical Analysis Plan  [PDF] November 21, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03014622    
Other Study ID Numbers: 1620301
First Posted: January 9, 2017    Key Record Dates
Results First Posted: July 21, 2022
Last Update Posted: July 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Revance Therapeutics, Inc.:
glabellar lines, frown lines
Additional relevant MeSH terms:
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abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents