Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fungal infection status in nail clippings measured by culture after laser treatment.
研究概览
简要总结
This study aims to assess if laser treatment can cure fungal infection in toenails.
Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.
详细描述
This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.
Potential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.
All interventions and mycological tests for each subject were performed over the course of one day.
After subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.
The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (>18 years)
- •Clinical suspicion of fungal infection in at least one toenail
- •Signed informed consent
- •Sufficient nail material to perform two cultures and one nail clipping
排除标准
- •Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month
- •Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy
- •Under the influence of alcohol or illegal narcotics
- •Unable to understand written and spoken Danish
结局指标
主要结局
Fungal infection status in nail clippings measured by culture after laser treatment.
时间窗: Approximately 10 minutes after treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.
Fungal infection status in nail clippings measured by microscopy before laser treatment.
时间窗: Approximately 10 minutes before treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.
Fungal infection status in nail clippings measured by culture before laser treatment.
时间窗: Approximately 10 minutes before treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.
Fungal infection status in nail clippings measured by microscopy after laser treatment.
时间窗: Approximately 10 minutes after treatment
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.
次要结局
- Nail clippings temperatures(Approximately 2 seconds after end of treatment.)
- Fungal infection status in nail clippings measured by PCR before laser treatment.(Approximately 10 minutes before treatment)
- Fungal infection status in nail clippings measured by PCR after laser treatment.(Approximately 10 minutes after treatment)
研究者
Christian Bisp Sørensen
Principal Investigator
Aalborg University Hospital