Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
研究概览
简要总结
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.
详细描述
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.
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
- Single (Outcomes Assessor)
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.
- •Skin laxity in the lower face and neck.
- •Willingness and ability to comply with protocol requirements and return for follow-up visits.
- •Provides written informed consent and HIPAA authorization.
排除标准
- •Pregnant or lactating.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Severe solar elastosis.
- •Excessive subcutaneous fat in the face and lower neck.
- •Excessive skin laxity on the face and neck.
- •Significant scarring in areas to be treated.
- •Significant open facial wounds or lesions.
- •Severe or cystic acne on the face.
- •Presence of a metal stent or implant in the facial area to be treated.
研究组 & 干预措施
Group A
Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.
干预措施: Ulthera® System treatment (Device)
Group B
Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
干预措施: Ulthera® System treatment (Device)
Group C
Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
干预措施: Ulthera® System treatment (Device)
结局指标
主要结局
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
时间窗: 90 Days post-treatment
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
时间窗: 90 Days post-treatment
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis. A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
次要结局
- Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.(90 days post-treatment)
- Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.(180 days post-treatment)
- Patient Satisfaction 90 Days Post-treatment(90 Days post-treatment)
- Patient Satisfaction Questionnaire 180 Days Post-treatment(180 days post-treatment)
- L'Oreal Photographic Scale Baseline(Baseline)
- L'Oreal Photographic Scale 90 Days Post-treatment(90 Days post-treatment)
- L'Oreal Photographic Scale 180 Days Post-treatment(180 Days post-treatment)
- Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.(60 days post-treatment)