MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines

Conditions
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Glabellar Lines, Lateral Canthal Lines

Intervention / Treatment
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* Drug: MT10109L
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria • Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Exclusion Criteria Known immunization or hypersensitivity to any botulinum toxin serotype. Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. History of facial nerve palsy. Any uncontrolled systemic disease. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention). Anticipated need for surgery or overnight hospitalization during the study. Prior exposure to botulinum toxin of any serotype for any reason. Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery). Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study. Females who are pregnant, nursing, or planning a pregnancy during the study. Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT10109L Dose 1 + Placebo<br>MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. | Drug: MT10109L<br>* MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.<br>* Other names: NivobotulinumtoxinA;Drug: Placebo<br>* Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.<br>|
| Experimental: MT10109L Dose 1 + MT10109L Dose 2<br>MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. | Drug: MT10109L<br>* MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.<br>* Other names: NivobotulinumtoxinA;|
| Placebo Comparator: Placebo<br>Placebo will be injected into the Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. | Drug: Placebo<br>* Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) | The outcome measured is the percentage of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Duration of Glabellar Line (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS). | Day 1 (first treatment) to Day 180 | 
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Day 30 | 
| The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Day 60 | 
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | The outcome was measured Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30 The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Day 30 | 
| Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE) | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier) | 
| Mean Change From Baseline in Systolic Blood Pressure (BP) | Changes in vital signs: Systolic BP | Baseline to Day 360 (Study exit) | 
| Mean Change From Baseline in Diastolic Blood Pressure (BP) | Changes in vital signs: Diastolic BP | Baseline to Day 360 (Study exit) | 
| Mean Change From Baseline in Pulse Rate | Changes in vital signs: Pulse Rate | Baseline to Day 360 (Study exit) | 
| Mean Change From Baseline in Respiratory Rate | Changes in vital signs: Respiratory Rate | Baseline to Day 360 (Study exit) | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | Change from baseline for ECG safety population - Heart Rate | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | Change from baseline for ECG safety population - PR Interval | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | Change from baseline for ECG safety population - QRS duration | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | Change from baseline for ECG safety population - QT interval | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | Change from baseline for ECG safety population - QTcB interval | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | Change from baseline for ECG safety population - QTcF interval | Baseline to Day 360 | 
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | Change from baseline for ECG safety population - RR interval | Baseline to Day 360 | 
| Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Day 360 |