NCT00935649已完成2 期
Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 8
- 主要终点
- Nail Bed Clearing
研究概览
简要总结
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
详细描述
The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers of either sex,
- •18-80 years of age,
- •Both great toes with clinical signs of infection.
- •Positive KOH or culture test
排除标准
- •Existing or history of cancer/skin malignancy,
- •Use of oral antifungal agents in past 6 months,
- •Use of topical antifungal agents in past 1 month,
- •Loss of protective sensation in either foot,
- •Infection involving lunula of either great toe,
- •Longitudinal streaks/spikes of either great toenail,
- •Distal nail thickness > 2 mm of either great toe,
- •Prior surgical treatment of either great toe in past 12 months,
- •Participation in another medical device/pharmaceutical study,
- •Condition that investigator determines makes it unsafe for subject to participate,
- •Pregnancy, breastfeeding or plans to become pregnant.
结局指标
主要结局
Nail Bed Clearing
时间窗: 48 weeks
Change in amount of clear nail over time.
次要结局
- Mycology(48 weeks)
研究者
研究点 (8)
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