Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With 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
- 20
- 试验地点
- 1
- 主要终点
- Treatment discomfort
研究概览
简要总结
This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.
详细描述
This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.
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, aged 30 to 65 years
- •Subject in good health
- •Skin laxity on the upper and lower face and neck
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
排除标准
- •Known sensitivity to ibuprofen, acetaminophen, or opiates
- •Presence of an active systemic or local skin disease that may affect wound healing
- •Severe solar elastosis
- •Excessive subcutaneous fat in the face and 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
Advil with Ultherapy
Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
干预措施: Advil (Drug)
Advil with Ultherapy
Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
干预措施: Ulthera System Treatment (Device)
Lortab with Ultherapy
Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
干预措施: Lortab (Drug)
Lortab with Ultherapy
Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Treatment discomfort
时间窗: During treatment
The validated NRS scale will be used to measure average pain scores reported by subject during treatment.
次要结局
- Improvement in skin laxity(90 days following treatment)