A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Improving the Appearance of fungal nail
研究概览
简要总结
The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.
详细描述
Toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of Americans. Onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. Current treatment options have relatively limited long-term success and recurrence is common.
The researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Male/ female has been diagnose with fungal nail infection on both great toenails.
排除标准
- •Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
- •Excessively thick or hypertrophic nails.
- •Subjects with diabetes.
- •Subjects that are pregnant
- •Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
- •Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
- •Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
- •History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.
结局指标
主要结局
Improving the Appearance of fungal nail
时间窗: 6 months
Laser treatment to Improve the Appearance of Onychomycosis
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery
University of California, Irvine