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Trial record 9 of 12 for:    DaxibotulinumtoxinA

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)

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: NCT03786770
Recruitment Status : Active, not recruiting
First Posted : December 25, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Brief Summary:
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 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 and Safety of DaxibotulinumtoxinA (DAXI) for Injection for the Treatment of Dynamic Forehead Lines (Frontalis) Following Glabellar Line Injections
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Cohort 1: Dose A
Subjects will receive DaxibotulinumtoxinA for injection for the treatment of FHL and GL.
Biological: DaxibotulinumtoxinA for injection
Intramuscular injection

Experimental: Cohort 2: Dose B
Subjects will receive DaxibotulinumtoxinA for injection for the treatment of FHL and GL.
Biological: DaxibotulinumtoxinA for injection
Intramuscular injection

Experimental: Cohort 3: Dose C
Subjects will receive DaxibotulinumtoxinA for injection for the treatment of FHL and GL.
Biological: DaxibotulinumtoxinA for injection
Intramuscular injection

Experimental: Cohort 4: Dose D
Subjects will receive DaxibotulinumtoxinA for injection for the treatment of FHL and GL.
Biological: DaxibotulinumtoxinA for injection
Intramuscular injection




Primary Outcome Measures :
  1. To evaluate the efficacy and safety of DAXI for injection in the treatment of dynamic FHL [ Time Frame: Baseline-Week 36 ]
    Proportion of subjects achieving a score of 0 or 1 (none or mild) in severity on the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale

  2. To evaluate the efficacy and safety of DAXI for injection in the treatment of dynamic FHL [ Time Frame: Baseline-Week 36 ]
    Incidence, severity, and relationship to study drug of treatment-emergent AEs (TEAEs) and serious adverse events (SAEs) during the overall study duration


Secondary Outcome Measures :
  1. To determine the responder rate of DAXI for injection in the treatment of FHL in conjunction with treatment for GL [ Time Frame: Baseline-Week 36 ]
    Proportion of subjects achieving an improvement of at least 1 point from baseline on the IGA FHWS.



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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 ICH-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 of age
  • Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the IGA-FHWS
  • Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the PFHWS
  • Have a score of moderate (2) or severe (3) GL during maximum frown based on the IGA-FWS scale
  • Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the PFWS
  • Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study
  • 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
  • Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
  • History of clinically significant bleeding disorders
  • Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example TCA or phenol) in the treatment areas within 3 months before enrollment through the end of the study
  • Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
  • History of upper or lower lid blepharoplasty or brow lift
  • Prior periorbital or forehead surgery

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): NCT03786770


Locations
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United States, Florida
Boca Raton site
Boca Raton, Florida, United States, 33431
Coral Gables site
Coral Gables, Florida, United States, 33146
Canada, Ontario
Toronto, Ontario site
Toronto, Ontario, Canada, M5R3N8
Woodbridge, Ontario site
Woodbridge, Ontario, Canada, L4L8E2
Sponsors and Collaborators
Revance Therapeutics, Inc.

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03786770     History of Changes
Other Study ID Numbers: 1820202
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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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.:
Forehead Lines
Glabellar Lines
Frown Lines