Comparative Study Between Fractional CO₂ Laser and 40% Urea Assisted Delivery of Topical Fluconazole Microemulsion in the Treatment of Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- comparison effect of fractioal co2 laser and 40% urea assisted delivery of topical fluconazole microemulsion in onychomycosis
研究概览
简要总结
To evaluate the efficacy and safety of topical fluconazole microemulsion enhanced by fractional CO₂ laser versus by 40% urea ablation in treatment of Onychomycosis.
详细描述
Onychomycosis is a common fungal infection of the nails, caused by dermatophytes, non-dermatophyte molds, and yeasts. The prevalence of onychomycosis is approximately 5.5% of the global population.
Trauma of the nail, aging, nail psoriasis, genetic predisposition and chronic diseases like Diabetes mellitus, immune deficient diseases are considered risk factors for onychomycosis.
Onychomycosis is clinically classified into different types which included:
Subungual onychomycosis which may be proximal (PSO) or distal lateral (DLSO), Endonyx onychomycosis and Total dystrophic onychomycosis (TDO).
Onychomycosis is a contagious disease and will not resolve without treatment leading to deterioration in the quality of life and having the potential to be a source of wider skin infection.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically and mycologically confirmed onychomycosis
- •No topical antifungal use in the past 1 month
- •No systemic antifungal use in the past 3 months
排除标准
- •pregnancy or lactation
- •Nail disorders such as psoriasis, eczema, lichen planus
- •patients have a known allergy to any of the study treatments
结局指标
主要结局
comparison effect of fractioal co2 laser and 40% urea assisted delivery of topical fluconazole microemulsion in onychomycosis
时间窗: one month after end of treatment
Onychomycosis Severity Index (OSI) score will be assessed for each patient Points were given based on : 1. The percentage of nail involvement (0-5points) 0% 0 point 1-10% 1 point 11-25% 2 points 26-50% 3 points 51-75% 4 points 76-100% 5 points 2. Proximity of disease to matrix (1-5 points) \<25% 1 point, 25-50% 2 points ,50-75% 3 points, \>75% 4 point, Matrix involvement 5 points 3. Dermatophytoma or subungual hyperkeratosis \> 2 mm. Present 10 points, Absent 0 points The score will be calculated by this equation: \[Score for percentage of involvement \* Score for the proximity of disease to the matrix + Score for dermatophytoma or subungual hyperkeratosis \> 2 mm\] Then the onychomycosis is classified as mild (1-5 points), moderate (6-15 points) or severe (16-35 points), zero indicates cured
次要结局
未报告次要终点
研究者
Shaza Alaa Ezzat Abdel-moneim
doctor
Assiut University