NCT01915355已完成不适用
Pulsed Dye Laser Treatment of Onychomycosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Total Nail Clearance
研究概览
简要总结
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.
Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.
详细描述
10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65 years old
- •Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping
排除标准
- •HIV/immunosuppression
- •Candidal toenail infection
- •Prior PO antifungal therapy within last 6 months
- •Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
- •Any serious generalized medical condition
结局指标
主要结局
Total Nail Clearance
时间窗: approximately 12 weeks
After 3 laser treatments, the subject should experience clinical clearance.
次要结局
未报告次要终点
研究者
研究点 (2)
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