A Phase 3, Multi-center, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
研究概览
简要总结
Facial lines (such as glabellar lines [GL], lateral canthal lines [LCL], and forehead lines [FHL]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be 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 BOTOX in Chinese adults with moderate to severe FHL.
Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study.
Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days.
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
- Triple (Participant, 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
- •Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
- •Participant must have symmetrical FHL of moderate or severe rating at maximum contraction as assessed by both investigator and participant using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
- •Participant must have glabellar lines (GL) severity of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
排除标准
- •Participants with history of known immunization or hypersensitivity to any botulinum toxin serotype.
- •Participants with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- •Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
- •Participant with history of treatments to the mid- or upper face.
研究组 & 干预措施
BOTOX
BOTOX will be injected on Day 1
干预措施: BOTOX (Drug)
Placebo
Placebo will be injected on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
时间窗: Day 30
The participant assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.
Number of Participants with Adverse Events (AEs)
时间窗: Day 180
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Percentage of Participants who Achieved 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity
时间窗: Day 30
The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.
次要结局
- Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Participant Assessment of FHL Severity(Baseline to Day 30)
- Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ follow up Item 4(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(Baseline to Day 30)
- Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity(Baseline to 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) follow up Item 5(Day 60)
- Percentage of Participants who Achieved at Least a 20-Point Psychosocial Impact Improvement from Baseline on the FLSQ Impact Domain(Baseline to Day 30)