NCT01124565已完成2 期
A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Assessment of treatment-emergent adverse events based on safety assessments.
研究概览
简要总结
This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.
详细描述
Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- •Previous participation in a RT001 clinical study
- •Previous treatment with botulinum toxin (any serotype)
研究组 & 干预措施
RT001
Experimental
RT001 (Botulinum Toxin Type A) Topical Gel
干预措施: RT001 (Drug)
结局指标
主要结局
Assessment of treatment-emergent adverse events based on safety assessments.
时间窗: 4 weeks and 8 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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