Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Onychomycosis severity index (OSI)
研究概览
简要总结
Study centre and address
King Chulalongkorn Memorial Hospital
Primary objective
To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5% amorolfine nail lacquer for toenail onychomycosis in Asians
详细描述
• Research Design
Randomized, single-blind clinical trial
• Research Methodology
Target population
- 42 Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically
- Patients were recruited from Dermatology clinic, King Chulalongkorn Memorial Hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically
- •Clinical signs of onychomycosis as following:
- •Discoloration
- •Dystrophy of nail plate
- •Subungual hyperkeratosis
- •Onycholysis
- •Confirmed by:
- •Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or
- •Positive microscopic evidence*
- •*any of these methods, direct microscopy (KOH preparation), nail plate culture on Sabouraud's dextrose agar (SDA), histopathological examination of nail clippings using PAS staining (HPE-PAS), histopathological examination of nail clippings using GMS staining (HPE-GMS), polymerase chain reaction
排除标准
- •Those with nail changes because of skin disease or associated systemic diseases
- •Pregnancy or lactating woman
- •Those who are allergic to amorolfine, methylene blue
- •Those who are photosensitive to visible light
- •Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
研究组 & 干预措施
MB-PDT for Onychomycosis
干预措施: Methylene blue-mediated photodynamic therapy (Procedure)
Amorolfine for Onychomycosis
干预措施: Amorolfine 5% Nail Lacquer (Drug)
结局指标
主要结局
Onychomycosis severity index (OSI)
时间窗: Change from baseline Onychomycosis severity index at every 2 weeks through the MB-PDT treatment completion, 12 weeks; then change from baseline Onychomycosis severity index at every 8 weeks through the study completion, an average of 18 months.
Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
次要结局
未报告次要终点
研究者
Einapak Boontaveeyuwat, MD
Asst. Prof.
Chulalongkorn University