A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 20
- 主要终点
- 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 LCL Severity at Maximum Smile at Day 30
研究概览
简要总结
To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MT10109L Dose 1 + Placebo
MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: MT10109L (Drug)
MT10109L Dose 1 + Placebo
MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: Placebo (Drug)
MT10109L Dose 1 + MT10109L Dose 2
MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: MT10109L (Drug)
Placebo
Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
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 LCL Severity at Maximum Smile at Day 30
时间窗: Day 30
The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.
次要结局
- Mean Change From Baseline in Respiratory Rate(Baseline to Day 360)
- Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)(AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval(Baseline to Day 360)
- The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)(Day 30)
- The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS(Day 1 (first treatment) to Day 180)
- The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)(Day 60)
- The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)(Day 30)
- Mean Change From Baseline in Systolic Blood Pressure (BP)(Baseline to Day 360)
- Mean Change From Baseline in Diastolic Blood Pressure (BP)(Baseline to Day 360)
- Mean Change From Baseline in Pulse Rate(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval(Baseline to Day 360)
- Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval(Baseline to Day 360)
- Number of Participants With Binding and Neutralizing Antibodies(Baseline to Day 360)