Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change from baseline in facial acne
研究概览
简要总结
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.
详细描述
Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.
- For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
- For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.
Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 years and older.
- •Subject in good health.
- •Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.
排除标准
- •Presence of >2 nodular lesions in the areas to be treated.
- •Presence of any cysts in the areas to be treated.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
- •History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- •History of keloid scar formation.
- •Significant scarring in areas to be treated.
- •Significant open facial wounds or lesions.
- •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 provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.
干预措施: Ulthera System Treatment (Device)
Group B
Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Change from baseline in facial acne
时间窗: 60 days post-treatment
Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
次要结局
- Change from baseline in skin clarity(180 days post-treatment)
- Reduction of sebum production(180 days post-treatment)
- Patient Satisfaction at 60 days(60 day post-treatment)
- Patient Satisfaction at 180 days(180 Days post-treatment)