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Trial record 6 of 12 for:    DaxibotulinumtoxinA

Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines

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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.

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

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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

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve a score of ≥ 1 on the investigator's assessment of GAIS [ Time Frame: From Week 2 to Week 24 ]
  2. 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 ]


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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

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.

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03014622     History of Changes
Other Study ID Numbers: 1620301
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: September 2019
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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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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