Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale
研究概览
简要总结
This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.
详细描述
This clinical investigation is a prospective study consisting of a screening/treatment visit and 5 follow-up visits. A total of 20 patients will be recruited.
Following informed consent and screening, each eligible subject will be photographed. Next, patients will be randomized to receive 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Patients randomized to each group will receive the same dosage injected to each neck band divided over 4 to 5 injection sites (up to 2 anterior and 2 lateral platysmal bands).
After randomization, patients will be treated with either 15 or 20 units per band. After treatment, subjects will be provided with post treatment instructions. Randomization will be conducted by having the patient pick either "15" or "20" out of a box. A total of 10 patients will be randomized to the 15 unit/platysmal band group. Another 10 patients will be randomized to the 20 unit/platysmal band group. The physician will fill out the 5-point Merz Neck Scale at baseline and at each follow-up visit. Photographs will be captured at each visit.
The patient will return at post-treatment weeks 8, 12, 16, 20, and 24. Subjects will fill out FACE-Q Satisfaction with Outcome surveys at each follow-up visit. FACE-Q Appraisal of Neck surveys will be filled out by the patient at the baseline and follow-up visits.
A blinded independent evaluator will evaluate the baseline and post-treatment photographs on Merz Neck Scale after completion of the study.
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
- None
入排标准
- 年龄范围
- 31 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>30 years old
- •Rating of 2, 3, or 4 on 5-point Merz Neck Scale
- •No use of any botulinum toxin in the neck for the past 6 months
排除标准
- •Pregnancy
- •Prior adverse reaction or known hypersensitivity to neuromodulators treatment
- •Connective tissue disorder
- •Scar in the treatment area
- •History of dysphagia and/or neuromuscular disorders (such as but not limited to Amyotrophic Lateral Sclerosis, Multiple sclerosis, Myasthenia Gravis, Lambert-Eaton syndrome, others per PI's discretion)
- •Active infection in treatment area
- •Active moderate or severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis
- •Prior treatment with neuromodulators in treatment area (neck) within the past 6 months
研究组 & 干预措施
DaxibotulinumtoxinA 20 units
Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
干预措施: DaxibotulinumtoxinA 20 units (Drug)
DaxibotulinumtoxinA 15 units
Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
干预措施: DaxibotulinumtoxinA 15 units (Drug)
结局指标
主要结局
Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale
时间窗: 3 months
Platysmal Neck Banding Scale (Scored on a 0-4 scale with 4 being the most severe)
次要结局
- Evaluate patient-reported outcomes (patient satisfaction with neck using FACE-Q scale)(3 months)
研究者
Kachiu Lee, MD
Physician
Main Line Center for Laser Surgery