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临床试验/NCT01915355
NCT01915355已完成不适用

Pulsed Dye Laser Treatment of Onychomycosis

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年7月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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