Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
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
- 4
- 主要终点
- Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
研究概览
简要总结
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-75 years.
- •Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies.
- •At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
- •HDSS score of 3 or
- •An attempt will be made to approximate an equal number of scores 3 and
- •Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .
排除标准
- •Dermal disorder including infection at anticipated treatment sites in either axilla.
- •Previous botulinum toxin treatment of the axilla in the past year.
- •Expected use of botulinum toxin for the treatment of any other disease during the study period.
- •Known allergy to starch powder, iodine, lidocaine, or epinephrine.
- •Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
- •Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
研究组 & 干预措施
Microfocused ultrasound with visualization
干预措施: Microfocused ultrasound with visualization (Device)
结局指标
主要结局
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
时间窗: Day 60 (30 days post second treatment)
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
次要结局
- Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment(Day 120 (90 days post second treatment))
- Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment(Days 60 (30 days post second treatment) and 120 (90 days post second treatment))
- Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment(Days 60 (30 days post second treatment) and 120 (90 days post second treatment))