Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 101
- 试验地点
- 5
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
详细描述
This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 25 to 70 years.
- •Subject in good health
- •Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.
- •Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.
- •Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.
- •Subjects who are identified with good photography, must have the ability to be contacted to provide authorization to disclose photographs for usage of previously taken photography, if photos are deemed worthy of publication.
排除标准
- •Subjects who have had any and all Ultherapy treatment(s) before April
- •Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.
- •Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Within 6 months before or after Ultherapy
An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers.
次要结局
未报告次要终点