A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, to Treat Moderate to Severe Lateral Canthal Lines in Adults.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.
详细描述
This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.
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
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male; 30 to 55 years of age
- •Bilateral lateral canthal lines rated as moderate or advanced
- •Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study
- •Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study
排除标准
- •Muscle weakness or paralysis in the area receiving study treatment
- •Active skin disease or irritation at the treatment areas
- •Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
- •Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
- •Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
- •Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure
研究组 & 干预措施
Dose A
RT001 Dose A; Active Comparator
干预措施: RT001 (Drug)
Dose B
RT001 Dose B; Active Comparator
干预措施: RT001 (Drug)
Dose C
RT001 Dose C; Active Comparator
干预措施: RT001 (Drug)
Dose D
RT001 Dose D; Active Comparator
干预措施: RT001 (Drug)
Dose E
RT001 Dose E; Vehicle Comparator
干预措施: Vehicle Comparator (Other)
结局指标
主要结局
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)
时间窗: Day 28
次要结局
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28)(Day 28)
- Incidence of treatment-emergent AEs(Day 28)