A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- the Change in Dynamic Strain in the Glabella Area After Injection Over Time
研究概览
简要总结
The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.
详细描述
This study is a randomized controlled trial in which patients will be randomly assigned into one of four groups: those receiving onabotulinumtoxinA (Botox, Allergan, Irvine, California), abobotulinumtoxinA (Dysport, Ispen Biopharmacueticals Inc.Cambridge, MA), incobotulinumtoxinA (Xeomin, Raleigh, NC) or prabotulinumtoxinA (Jeuveau, Evolus, Newport Beach, California). Each patient will receive FDA approved dosages in which they are assigned in to treat rhytids within the glabella, as per FDA approved indications. All injections will be performed by a blinded single trained physician according to a preset injection plan per FDA approved administration guidelines. Prior to injection patients will be imaged with 3-dimensional photogrammetry. All pre-procedure images will be evaluated for absolute strain performing two types of facial animation: 1) relaxed, and 2) frowning. Subjects will return Day 3, 30, 90, and 180, post intervention for re-imaging with the same expressions. Strain will be calculated using the same metrics.
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, Care Provider)
盲法说明
blinding of participant and provider administering the treatment
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •30-65 years of age
- •Interested in glabellar injections to reduce rhytids and facial strain
- •Participants must sign the informed consent form
排除标准
- •Females under 30 or above 65 years of age
- •Those who have received glabellar injections for rhytids <12 months
- •Underwent cosmetic surgical procedure above the malar region
- •Those with a condition that affects facial expression, such as prior stroke
研究组 & 干预措施
OnabotulinumtoxinA
Botox
干预措施: Onabotulinumtoxina for Injection (Drug)
AbobotulinumtoxinA
Dysport
干预措施: Abobotulinumtoxina for Injection (Drug)
IncobotulinumtoxinA
Xeomin
干预措施: IncobotulinumtoxinA for Injection (Drug)
PrabotulinumtoxinA
Jeuveau
干预措施: PrabotulinumtoxinA for Injection (Drug)
结局指标
主要结局
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
时间窗: day 3, day 30, day 90, day 180
The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.
次要结局
- Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime(baseline, day 3, day 30, day 90, day 180)