NCT01452490已完成不适用
Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
ConBio, a Cynosure Company2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement
研究概览
简要总结
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
- •Fitzpatrick Skin Type I-IV
- •Written and verbal informed consent
- •Able to comply with study instructions and to return to the clinic for required visits
- •Agrees to refrain from other active topical, laser or light-based treatment to the great toes
- •Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis
排除标准
- •Pregnancy, breastfeeding or planning to become pregnant
- •History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
- •Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
- •Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
- •Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
- •Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
- •Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
- •Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
- •Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
- •Immunocompromised status, or with existing (or history of) cancer/skin malignancy
- •Distal nail thickness of greater than 2mm in the affected great toenail
研究组 & 干预措施
Diode Laser Treatment
Experimental
干预措施: Diode Laser Treatment (Device)
结局指标
主要结局
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement
时间窗: 12 months
Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.
次要结局
未报告次要终点
研究者
研究点 (2)
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