NCT01811004已完成不适用
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Sweating Assessed Using Gravimetry
研究概览
简要总结
The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy non-smoking male or female between 18-70 years of age
- •Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment
- •Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
- •Clinically diagnosed for primary hyperhidrosis of the axilla.
- •A self-assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4) a. Gravimetric >50mg/5min in each axilla
排除标准
- •Clinical diagnosis of secondary hyperhidrosis
- •Uncontrolled systemic disease or infection
- •Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants
- •Receipt of Botox® or Dysport® within the past six months
- •Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed.
- •Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except OTC antiperspirant or planning to use such agents during the course of the study.
- •Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months
- •Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
- •Is susceptible to light induced seizures or history of seizures
- •Has a history of keloid formation
- •Significant cardiovascular disease
- •Bleeding disorders
- •Anti-platelet and anticoagulant medication
- •Sensitivity to lidocaine or epinephrine
- •Pregnancy or planned pregnancy
- •Existing neuromuscular disorders (myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis)
- •Electronic implants
- •Subjects requiring supplemental oxygen
- •Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
- •Allergic to Keflex
结局指标
主要结局
Change in Sweating Assessed Using Gravimetry
时间窗: 9 month follow up
A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced.
次要结局
未报告次要终点
研究者
研究点 (2)
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