A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of onabotulinumtoxinA in Japanese adults with moderate to severe FHL.
Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan.
In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
- •Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- •Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]).
排除标准
- •FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- •History of known immunization or hypersensitivity to any botulinum neurotoxin serotype.
- •History of treatments to the mid or upper face.
研究组 & 干预措施
Group 2
Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.
干预措施: OnabotulinumtoxinA (Drug)
Group 3
Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
干预措施: OnabotulinumtoxinA (Drug)
Group 4
Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.
干预措施: OnabotulinumtoxinA (Drug)
Group 1
Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.
干预措施: OnabotulinumtoxinA (Drug)
Group 3
Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
干预措施: Placebo (Drug)
Group 4
Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 12 months
Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction
时间窗: Day 30
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
次要结局
- Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale(Day 30)
- Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit(Day 30)
- Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity(Day 30)
- Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction(Day 30)
- Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest(Day 30)
- Time to Return to at least 'Moderate' for the Participants who Achieve Investigator FWS-A ratings of 'None' or 'Mild' on FHL Severity at Maximum Contraction(Day 30)
- Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ)(Day 60)
- Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ(Day 30)