Comparative evaluation of efficacy of ‘urea application followed by CO2 laser ablation’ and ‘nail avulsion’ as an adjuvant to conventional therapy in treatment of Onychomycosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- 1) Clinical cure rate by nail examination and photographic evaluation
研究概览
简要总结
Currently available treatment options for onychomycosis such as topical and systemic antifungals are often of limited efficacy, difficult to administer or associated with relevant side effects. The disease is notoriously difficult to treat due to the deep-seated nature of fungi within the nail plate, prolonged treatment requirements, poor patient adherence and frequent recurrences. Given the poor efficacy of currently available topical and systemic therapies, there is a renewed interest in exploring alternative treatment modalities for onychomycosis.
Aim of the current study is to compare the benefit of adding urea application followed by CO2 laser ablation and nail avulsion as an adjuvant to conventional therapy in treatment of onychomycosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of fungus in nail clipping demonstrated by KOH/fungal culture 2) Dermoscopic findings suggestive of Onychomycosis.
排除标准
- •Individuals with photosensitive dermatoses 2) Individuals with contraindications to CO2 laser therapy like Isotretinoin use within the previous six months, history of keloid formation or hypertrophic scarring, ongoing ultraviolet exposure, prior radiation therapy to treatment area, collagen vascular disease 3) Individuals with deranged bleeding time, clotting time, PT, APTT 4) Individuals on antiplatelet therapy (Aspirin, clopidogrel, ticagrelor, etc) 5) Pregnant and lactating women.
结局指标
主要结局
1) Clinical cure rate by nail examination and photographic evaluation
时间窗: At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
2) Mycological cure rate by KOH microscopic examination
时间窗: At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
3) Change in OSI (onychomycosis severity index score)
时间窗: At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
次要结局
- 1) To study adverse drug reactions due to topical and oral antifungal agents(2) To study post operative complications after nail avulsion)