Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Wrinkles Score
研究概览
简要总结
The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.
详细描述
Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females age 18 or older.
排除标准
- •Previous treatment with a neuromodulator in the last 6 months
- •previous brow lift
- •currently pregnant or breastfeeding
- •a history of neurological disease or deficit
- •an active facial skin infection
- •an allergy to neuromodulators
研究组 & 干预措施
Xeomin right side; Xeomin to left side of face
Patients were randomized as to which side of the face was treated with Xeomin.
干预措施: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects (Drug)
Botox right side; Botox to left side
Patients were randomized as to which side of the face was treated with Botox.
干预措施: Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects (Drug)
结局指标
主要结局
Change in Wrinkles Score
时间窗: Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection
Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the "Validated Assessment Scaled for the Upper Face" published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated.
次要结局
未报告次要终点
研究者
Ruth Hill Yeilding
MD
YMD Eye and Face
