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临床试验/NCT02122536
NCT02122536已完成不适用

Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA

YMD Eye and Face1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

发起方
YMD Eye and Face
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Hill Yeilding

MD

YMD Eye and Face

研究点 (1)

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