NCT00842062已完成1 期
Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.
研究概览
简要总结
A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subject must be a female 30 to 70 years of age.
- •The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity.
- •The subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis).
- •The subject must have signed an informed consent form.
- •The subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months.
- •The subject should not be participating in any other facial cosmetic research study.
排除标准
- •The subject is on a regular regimen of prescribed or over-the-counter anticoagulants.
- •The subject has an infection or skin problem at the injection site.
- •The subject has a history of facial nerve palsy.
- •The subject has marked facial asymmetry.
- •The subject has ptosis.
- •The subject has excessive dermatochalasis.
- •The subject has deep dermal scarring.
- •The subject has thick sebaceous skin.
- •The investigator is unable to substantially lessen facial lines by physical separation.
- •The subject has a history of neuromuscular disorder.
- •The subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated.
- •Subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet.
- •The subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.
时间窗: Up to 6 months
次要结局
- Incidence of adverse events(Up to 6 months)
研究者
研究点 (2)
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