NCT03022903已完成不适用
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of subjects with clinical cure based on photographs after the 3rd treatment session
研究概览
简要总结
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
详细描述
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 19 and younger than 70 years
- •Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- •Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum
- •No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks
- •At lease 20% of target great toe nail affected
排除标准
- •Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance)
- •Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis
- •Patients with greater than 6 toenails affected
- •Over 90% of target great toe affected
- •Evidence of fingernail fungal infection
- •Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection
- •Patients with known history of HIV or hepatitis B or C infection
- •Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease
- •Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
结局指标
主要结局
Number of subjects with clinical cure based on photographs after the 3rd treatment session
时间窗: 3 weeks after baseline
Based on visual assessment of photographs: presence or absence of fungal infection
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
时间窗: 3 weeks after baseline
Based on presence of fungal infection from culture assessment
次要结局
- Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks(24 weeks after first treatment)
- Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit(3 weeks after baseline)
- Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times(3 weeks after baseline)
研究者
Boni Elewski
Principal Investigator
University of Alabama at Birmingham
研究点 (2)
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