Clinical trial NCT04259086: Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection (DAXI for Injection) for the Combined Treatment of Upper Facial Lines (Glabellar Lines, Dynamic Forehead Lines and Lateral Canthal Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
Keywords: Lateral Canthal Wrinkle
crow's feet lines
LCL
Forehead Lines
Glabellar Lines
Frown Lines
Upper facial lines
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
2. Be outpatient, male or female subjects, in good general health, 18 years of age or older
3. Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
4. Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
5. Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
6. Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study

Exclusion Criteria:

1. Active skin disease, infections, or inflammation at the injection sites
2. Planned or anticipated need for surgery or hospitalization through the end of the study
3. Pregnant, nursing, or planning a pregnancy during the study; or is a Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
4. Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening

Primary outcomes:
measure: Percentage of Participants With None or Mild in GL Severity at Maximum Frown
timeFrame: Week 4
measure: Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
timeFrame: Week 4
measure: Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: Site 1
state: California
city: San Diego
country: United States
facility: Site 3
state: California
city: Santa Monica
country: United States
facility: Site 7
state: California
city: Coral Gables
country: United States
facility: Site 5
state: Florida
city: Chestnut Hill
country: United States
facility: Site 2
state: Massachusetts
city: New York
country: United States
facility: Site 6
state: New York
city: Vancouver
country: Canada
facility: Site 4
state: British Columbia
city: Toronto
country: Canada
facility: Site 8
state: Ontario
Study officials:
References: