Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full 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
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants with Lifting and Tightening of Skin
研究概览
简要总结
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. 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 is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also 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, 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, age 30 to 65 years.
- •Subject in good health.
- •Skin laxity on the area(s) to be treated.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- •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.
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 area(s) to be treated.
- •Excessive skin laxity on the area(s) to be treated.
- •Significant scarring in the area(s) to be treated.
- •Open wounds or lesions in the area(s) to be treated.
- •Severe or cystic acne on the area(s) to be treated.
- •Presence of a metal stent or implant in the area(s) to be treated.
- •Inability to understand the protocol or to give informed consent.
- •Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
- •Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- •BMI equal to or greater than 25.
研究组 & 干预措施
Group A
Ulthera System Treatment Right, Thermage Left
干预措施: Ulthera System Treatment (Device)
Group A
Ulthera System Treatment Right, Thermage Left
干预措施: Thermage (Device)
Group B
Ulthera System Treatment Left, Thermage Right
干预措施: Ulthera System Treatment (Device)
Group B
Ulthera System Treatment Left, Thermage Right
干预措施: Thermage (Device)
结局指标
主要结局
Number of Participants with Lifting and Tightening of Skin
时间窗: 180 days post treatment
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Number of Participants with Wrinkle Reduction
时间窗: 180 days post treatment
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
次要结局
- Number of Participants with Eyebrow Lift(90 days post-treatment)
- Number of Participants with Lower face and Neck Lift(90 days post-treatment)
- Number of Participants Reporting Treatment Satisfaction(180 days post-treatment)