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Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal 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: NCT03911102
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Study Description
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Brief Summary:
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Biological: DaxibotulinumtoxinA for injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: DaxibotulinumtoxinA Dose A
Subjects will receive Dose A of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 2: DaxibotulinumtoxinA Dose B
Subjects will receive Dose B of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 3: DaxibotulinumtoxinA Dose C
Subjects will receive Dose C of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 4: DaxibotulinumtoxinA Dose D
Subjects will receive Dose D of DaxibotulinumtoxinA for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. The incidence, severity, and relationship to study drug of treatment-emergent Adverse Events (AEs) (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline-Week 36 ]
    Number of participants with TEAEs and SAEs will be evaluated (safety and tolerability)

  2. Proportion of subjects achieving a score of 0 or 1 (none or mild) in Lateral Canthal Lines (LCL) severity on the Investigator Global Assessment Lateral Canthal Wrinkle Severity scale [ Time Frame: Baseline-Week 36 ]
    Evaluate the efficacy of DAXI for injection using the proportion of subjects achieving a score of 0 or 1 (none or mild) in LCL severity on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale


Secondary Outcome Measures :
  1. The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL) [ Time Frame: Baseline-Week 36 ]
    The responder rate is determined by the proportion of subjects achieving a score of 0 or 1 (none or mild) in Lateral Canthal Lines (LCL) severity at maximum smile on the Patient Lateral Canthal Wrinkle Severity (PLCWS) scale at 4 weeks after Lateral Canthal Lines (LCL) treatment

  2. The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL) [ Time Frame: Baseline-Week 36 ]
    The responder rate is determined by the proportion of subjects achieving an improvement of at least 1 point from baseline in LCL severity at maximum smile on the IGA-LCWS at Week 4 after LCL treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
  • Be outpatient, male or female subjects, in good general health, 18-65 years old
  • Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
  • Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

  • Active skin disease, infections, or inflammation at the injection sites
  • History of clinically significant bleeding disorders
  • Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
  • Planned or anticipated need for surgery or hospitalization through the end of the study
  • Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study
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): NCT03911102


Locations
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United States, California
Sacramento, CA Site
Sacramento, California, United States, 95816
United States, Florida
Sarasota, FL Site
Sarasota, Florida, United States, 34239
United States, Illinois
Itasca, IL Site
Itasca, Illinois, United States, 60143
United States, Virginia
Arlington, VA Site
Arlington, Virginia, United States, 22209
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
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Study Director: Dom Vitarella Revance Therapeutics, Inc.
More Information
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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03911102    
Other Study ID Numbers: 1820205
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revance Therapeutics, Inc.:
Lateral canthal wrinkle
Crow's feet lines
LCL
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents