Efficacy of combining CO2 laser with Amrolofine 5% nail laqure intreatment of Onychomycosis- An open label randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2. Change in OSI from baseline to 24 weeks within both the groups.
研究概览
简要总结
As per the S1 guidelines for onychomycosis, current management option for mild to moderate onychomycosis are topical antifungal.The main drawback with these drugs are longer treatment duration and poor efficacy, CO2 laser may contribute to inhibiting fungal growth by causing vaporization and exfoliation of the local tissue around the affected nail. This process leads to diffuse remodeling and simultaneously destroys the fungal growth environment. Addition of CO2 laser with conventional topical antifungal may improve clinical efficacy rate, decreases the duration of treatment and chances of replase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All diagnosed patients of onychomycosis (clinically and mycologically) with age more than 12 years
- •Patients with distal subungual onychomycosis, white superficial onychomycosis, max.
- •40 percent of the nail surface affected.
- •Patients with mild to moderate onychomycosis (with OSI less than equal to 15)
- •Patients who are willing for CO2 lser.
排除标准
- •Patients having localized bacterial infection around the affected nail or concomitant nail disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment.
- •Patients with history of intake of oral antifungal medication within the last 3 months or the use of topical antifungal medication within the last 2 weeks prior to the laser treatment.
- •Pregnant patient.
结局指标
主要结局
2. Change in OSI from baseline to 24 weeks within both the groups.
时间窗: Baseline, 18 weeks, 24 weeks
1. Percentage of nail achieving of CER and MCR at the end of 24 week and its
时间窗: Baseline, 18 weeks, 24 weeks
comparision between the 2 group.
时间窗: Baseline, 18 weeks, 24 weeks
次要结局
- 1. Comparision of recurrence rate in both the group during 3 month follow up after(completion of CO2 laser treatment.)