Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Subjects' Assessment of Pain During Treatment With Lower Energy Settings
研究概览
简要总结
Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
详细描述
This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
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, Investigator)
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, age 30 to 65 years.
- •Subject in good health.
- •Skin laxity on the face and neck
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Severe solar elastosis.
- •Excessive subcutaneous fat in the face or neck.
- •Excessive skin laxity on the face or neck.
- •Significant scarring in areas to be treated.
- •Open wounds or lesions in the area to be treated.
- •Severe or cystic acne on the area to be treated.
研究组 & 干预措施
Group A
Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.
干预措施: Ulthera System Treatment (Device)
Group B
Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.
干预措施: Ulthera System Treatment (Device)
Group C
Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Subjects' Assessment of Pain During Treatment With Lower Energy Settings
时间窗: Participants were assessed for the duration of study treatment, an average of 75 minutes
Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.
Overall Improvement in Skin Laxity on the Face and Neck
时间窗: 90 days post-treatment
A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.
次要结局
- Subject Assessment of Improvement at 90 Days Post-treatment(90 days post-treatment)
- Subject Assessment of Improvement at 180 Days Post-treatment(180 days post-treatment)
- Quantitative Assessment of Brow Lift at 90 Days Post-treatment(90 days post-treatment)