Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Upper Face Wrinkle Severity 4 Months After Botox Administration
研究概览
简要总结
This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-65
- •In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration
排除标准
- •Current use of aminoglycosides, curare like agents, and muscle relaxants
- •Pregnancy or lactation
- •Known allergic reactions to components of the botox formulation and any of its ingredients
- •Treatment with another botox product for the face within 4 months
- •Infections/preexisting weakness at the proposed injection sites on physical examination
- •History of neuromuscular disorder, pre existing severe cardiovascular disease, compromised respiratory function, severe dysphagia
- •Pediatric population, patients older than 65 since the effect of botox in terms of duration and magnitude is highly variable in these age groups.
研究组 & 干预措施
Standard Dosing Group
干预措施: OnabotulinumtoxinA Standard Dose (Drug)
Half Standard Dosing Group
干预措施: OnabotulinumtoxinA Half Standard Dose (Drug)
结局指标
主要结局
Upper Face Wrinkle Severity 4 Months After Botox Administration
时间窗: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Patient Satisfaction 1 Month After Botox Administration
时间窗: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 2 Months After Botox Administration
时间窗: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Upper Face Wrinkle Severity 1 Week After Botox Administration
时间窗: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Upper Face Wrinkle Severity 3 Months After Botox Administration
时间窗: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Patient Satisfaction 1 Week After Botox Administration
时间窗: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Upper Face Wrinkle Severity 1 Month After Botox Administration
时间窗: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
Patient Satisfaction 3 Months After Botox Administration
时间窗: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Patient Satisfaction 4 Months After Botox Administration
时间窗: 4 Months
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
Upper Face Wrinkle Severity 2 Months After Botox Administration
时间窗: 4 Months
The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months.
次要结局
未报告次要终点