A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of 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
- 90
- 试验地点
- 1
- 主要终点
- The number of subjects who show improvement based on the investigator global and patient assessments.
研究概览
简要总结
The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.
详细描述
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.
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
- 是
入选标准
- •Written informed consent including authorization to release health information
- •Female or male, 18 to 65 years of age and in good general health
- •Willing and able to follow study instructions and likely to complete all study requirements
- •Moderate to severe lateral canthal lines (crow's feet wrinkles)
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- •Muscle weakness or paralysis, particularly in the area receiving study treatment
- •Active disease or irritation at the treatment areas including the eye and the skin
- •Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
- •Previous participation in a RT001 clinical study
研究组 & 干预措施
Dose A
RT001 Topical Gel
干预措施: Botulinum Toxin Type A (Drug)
Dose B
Placebo Comparator
干预措施: Placebo (Dose B) (Drug)
结局指标
主要结局
The number of subjects who show improvement based on the investigator global and patient assessments.
时间窗: Week 4
次要结局
- The number of subjects who show improvement based on the investigator global and patient assessments.(Week 8)