Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
研究概览
简要总结
The main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
The study is a low-intervention, randomised controlled clinical trial. Patient recruitment will be done by including in the sample those patients who have diagnostic confirmation of onychomycosis in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid. Participants in the trial will be assigned with equal probability to each treatment arm, according to their consecutive inclusion in the study. Subsequently, treatment assignment will be determined by a random code. The treatment used will be evident to both the participant and the podiatrist responsible for the intervention.
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
详细描述
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
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 (Investigator)
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
- •Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
- •Patients over 18 years of age.
排除标准
- •Patients who have received topical or systemic antifungal treatment in the previous month.
- •Pregnancy or lactation.
- •Patients with peripheral vascular disease.
- •Patients with an immune system disorder or undergoing treatment with immunosuppressants.
- •Patients with peripheral or central neuropathy.
- •Patients with a coagulation disorder.
- •Patients with Raynaud's disease or with any alteration in the perception of cold or heat.
研究组 & 干预措施
Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)
According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
干预措施: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (Device)
Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.
干预措施: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer (Drug)
结局指标
主要结局
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
时间窗: 12 months
Complete cure (yes/no)
次要结局
- To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve clinical cure of onychomycosis.(12 months)
- To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve, mycological cure of onychomycosis.(12 months)
- To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve complete cure of onychomycosis.(12 months)
- To analyse the influence of the type of onychomycosis on the response to treatment.(12 months)
- To analyse the influence of the causal fungal agent on the response to treatment.(12 months)
- To analyse the influence of the degree of severity of onychomycosis on the response to treatment.(12 months)
研究者
FRANCISCO JAVIER ALVARO AFONSO
Principal Investigator
Universidad Complutense de Madrid