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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: NCT03014635
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 : 306 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-2)
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : November 3, 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): NCT03014635


Locations
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United States, California
Encinitas, California, United States, 92024
Los Angeles, California, United States, 90069
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Illinois
Naperville, Illinois, United States, 60563
United States, Louisiana
New Orleans, Louisiana, United States, 70124
United States, Nebraska
Omaha, Nebraska, United States, 68144
United States, New York
West Islip, New York, United States, 11795
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Washington
Spokane, Washington, United States, 99202
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Ontario
Burlington, Ontario, Canada, L7N 3N2
Toronto, Ontario, Canada, M5R 3N8
Woodbridge, Ontario, Canada, L4L 8E2
Canada, Quebec
Montreal, Quebec, Canada, H3Z 1B7
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: NCT03014635    
Other Study ID Numbers: 1620302
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