NCT00968942已完成2 期
A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single 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
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
- 36
- 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-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.
详细描述
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.
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
- •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
- •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 neuromuscular 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 lift 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
- •Clinically significant laboratory values at Screening
研究组 & 干预措施
Dose A
Active Comparator
RT001
干预措施: Botulinum Toxin Type A (Drug)
Dose B
Placebo Comparator
Placebo
干预措施: Placebo (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-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs
时间窗: Week 8
次要结局
- The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs(Weeks 2, 4, 6, 8)
研究者
研究点 (1)
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