AVALIAÇÃO DO USO DO LASER ERBIUM-DOPED YTTRIUM ALUMINIUM GARNET (Er:YAG) ASSOCIADO AO ESMALTE DE AMOROLFINA NO TRATAMENTO DA ONICOMICOSE
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Extent of nail plate damage
研究概览
简要总结
The study aims to investigate the effectiveness of a single application of Er:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.
详细描述
This is a trial study involving 30 subjects with onychomycosis of hands or feet. The patient must have at least 2 injured nails as each affected nail will receive a different treatment - self-controlled study design.
Therefore, each nail out of two from a single patient will be randomized into the following study arms:
Group A of nails - will receive only weekly application of amorolfine lacquer for a total of 6 months.
Group B of nails - will receive a single application of Er:YAG laser followed by weekly application of amorolfine lacquer for a total of 6 months.
At the end of 6 months the data from both groups, A and B, regarding *clinical cure, *mycological cure and *extent of damage to the nail plates will be analyzed using specific tests.
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
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-60 year-old
- •preserved cognitive status
- •direct mycological examination or culture showing infection of hands or feet nails by dermatophyte molds
排除标准
- •diabetes type 1 or 2; peripheral vascular disease
- •having undergone any treatment in the last 6 months
- •peripheral nerve disorders (e.g. peripheral neuropathy, Hansen's disease, etc)
- •willing to paint nail during the study
- •high blood pressure
- •use of any immunosuppressive drugs; congenital or acquired immunodeficiency
研究组 & 干预措施
Amorolfine lacquer
30 ungual units affected by onychomycosis due to dermatophytes
干预措施: Amorolfine lacquer (Drug)
结局指标
主要结局
Extent of nail plate damage
时间窗: 6 months
At the beginning and after 6 months of treatment both the group, A and B, will have the length from nail cuticle to the closest point of damage to the nail plate measured by a millimeter scale. It will later be accessed to determine the clearance rate of the nail plate achieved with each treatment
次要结局
- Mycological cure(6 months)
- Clinical cure(6 months)
研究者
Izelda Maria Carvalho Costa
Adjunct Professor
Brasilia University Hospital