Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in submental volume
研究概览
简要总结
Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.
详细描述
This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 30 to 65 years
- •Subject in good health
- •Body Mass index of less than 30
- •Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- •Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
- •Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
- •Willingness and ability to comply with protocol requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
- •Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control
排除标准
- •Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
- •Has an active systemic or local skin disease that may alter wound healing
- •Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
- •Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
研究组 & 干预措施
Group A
Subjects who have previous history of submentoplasty and or rhytidectomy
干预措施: Ulthera System Treatment (Device)
Group B
Subjects naïve to submentoplasty and or rhytidectomy
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Change in submental volume
时间窗: 90 days post-treatment
Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
次要结局
- Overall improvement of the submental area(90 days post-treatment)