Clinical trial NCT03004248: Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
Official title: An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Keywords: glabellar lines, frown lines
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 2691
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 long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAE)
timeFrame: 0-36 weeks
Secondary outcomes:
measure: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
timeFrame: Week 4
measure: The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
timeFrame: 0-36 weeks per cycles 1 and 2
measure: The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
timeFrame: 0-36 weeks per Cycle 1 and 2
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Fremont
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Manhattan Beach
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Greenwood Village
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Lincolnshire
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Glenn Dale
country: United States
state: Maryland
city: Hunt Valley
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Chestnut Hill
country: United States
state: Massachusetts
city: Birmingham
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Montclair
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: West Islip
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Drexel Hill
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Mequon
country: United States
state: Wisconsin
city: Vancouver
country: Canada
state: British Columbia
city: Burlington
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Woodbridge
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
Study officials:
References:
citation: Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.
citation: Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531.