Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
研究概览
简要总结
The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.
详细描述
Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.
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
- 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
- 是
入选标准
- •Have Onychomycosis on at least one toe.
- •Age 18 or older.
- •Consent to research use of their toenail clippings.
排除标准
- •Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
- •Pregnant female.
- •Age 75 or older.
研究组 & 干预措施
Treatment
- st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
- nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
干预措施: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser) (Device)
Placebo
- st visit: For the control group, no treatment will be given.
- nd visit: 2 weeks after initial visit, patient will be seen for second visit
结局指标
主要结局
The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
时间窗: 1 year
次要结局
- Proximal Clearance of Fungus on Nail(1 year)
研究者
Jean Yuh Tang
Assistant Professor of Dermatology
Stanford University