Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: Botulinum Toxins, Type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DaxibotulinumtoxinA 40 units<br>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection | Biological: Botulinum Toxins, Type A<br>* Intramuscular Injection<br>* Other names: DaxibotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events (TEAE) | Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period. | 0-36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e. none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments | Week 4 | 
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle. | 0-36 weeks per cycles 1 and 2 | 
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle. | 0-36 weeks per Cycle 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glabellar lines, frown lines