Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- treatment of onychomycosis
研究概览
简要总结
Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.
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
- 是
入选标准
- •• Age group >18 years.
- •Patients of both genders.
- •Patients with OM any type.
排除标准
- •• Pregnancy
- •Localized bacterial infection around the affected nail
- •Concomitant nails disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment
- •Hypersensitivity to terbinafine
- •Intake of oral antifungal medication within the last 3 months or used topical antifungal medication within the last 2 weeks prior to the laser treatment
研究组 & 干预措施
Fractional CO2 laser combined with topical tioconazole
Fractional CO2 laser (10,600 nm) will be done. The sessions will be done every 2 weeks.
Topical tioconazole 28% nail solution will be applied in between the sessions twice daily
干预措施: Topical tioconazole (Drug)
Q switched ND-Yag
Laser protocol with a specific parameters will be applied on the affected nails. In one session two passes across each nail plate will be performed with two minutes pauses between each pass. Sessions will be done every 2 weeks
干预措施: Topical tioconazole (Drug)
结局指标
主要结局
treatment of onychomycosis
时间窗: 6 months
Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement
次要结局
未报告次要终点