Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: Botulinum Toxins, Type A
* Biological: Placebos


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
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


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;|
| Placebo Comparator: Placebo<br>Biological/Vaccine: Placebos Intramuscular injection | Biological: Placebos<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. | 0-36 weeks | 
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. | 0-36 weeks | 

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