Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Improvement in lower face and neck skin laxity
研究概览
简要总结
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
详细描述
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. 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
- 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 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 in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- •Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
- •Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
排除标准
- •Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Severe solar elastosis.
- •Excessive subcutaneous fat on the cheeks.
- •Excessive skin laxity on the lower face and 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
Ulthera treatment group
All subjects will receive an Ulthera System Treatment
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Improvement in lower face and neck skin laxity
时间窗: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline
Cervicomental angle
时间窗: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline.
次要结局
- Patient satisfaction(90 days post-treatment)
- Pain Assessment(Treatment visit)
- Patient Satisfaction(180 days post-treatment)
- Overall aesthetic improvement(180 days post-treatment)