NCT00968825已完成2 期
A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Administration of RT001, a Botulinum Toxin Type A 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
- 73
- 试验地点
- 1
- 主要终点
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a single administration of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal lines.
详细描述
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the efficacy and safety of a single administration of RT001 compared to placebo applied as a bilateral application in at least 72 subjects with moderate to severe Lateral Canthal Lines. Subjects will be randomized within each site to 1 of 2 treatment groups in a 1:1 ratio. The efficacy and safety of RT001 compared to placebo will be evaluated. Study follow-up visits will occur at Weeks 2, 4 and 6.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male, 30 to 60 years of age
- •Bilateral lateral canthal lines rated as moderate or severe based on the Investigator Global Assessment - Lateral Canthal Lines Rest and Investigator Global Assessment - Lateral Canthal Lines Smile Severity Scales
- •Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study (Week 6)
- •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
- •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 euromuscular junctional disorders
- •Muscle weakness or paralysis in the area receiving study treatment
- •Active skin disease or irritation at the treatment areas
- •Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
- •Use of prescription retinoid products during the past 3 months prior to Screening
- •Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
- •Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow left or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
- •Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
- •Previous treatment with Botulinum Toxin Type A in the face area
- •Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
- •Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at Screening
- •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 (Week 6)
- •Clinically significant laboratory values at Screening
研究组 & 干预措施
Dose E
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Dose D
Active Comparator
RT001
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs
时间窗: Week 4
次要结局
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest and Smile from Baseline (Day 0) to Week 4 and Baseline (Day 0) to Week 6; incidence of treatment emergent AEs(Week 4 and Week 6)
研究者
研究点 (1)
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