Study of the effectiveness of fractional CO2 laser therapy combined with 8 percent ciclopirox nail lacquer Vs ciclopirox nail lacquer alone in Onychomycosis Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Clinical cure – improvement in nail appearance, reduction in discoloration and thickness, assessed at 12 weeks and 24 weeks.
研究概览
简要总结
This randomized controlled clinical trial is designed to evaluate the effectiveness of Fractional CO2 laser therapy combined with 8 percent Ciclopirox nail lacquer compared to 8 percent Ciclopirox nail lacquer alone in the treatment of onychomycosis. The study hypothesis is that the combination of Fractional CO2 laser therapy with topical Ciclopirox will achieve superior clinical and mycological cure rates compared to topical Ciclopirox alone. Eligible participants will be randomized into two groups. The intervention arm will receive Fractional CO2 laser therapy along with daily application of Ciclopirox 8 percent nail lacquer. The control arm will receive Ciclopirox 8 percent nail lacquer alone. Primary outcomes will include clinical cure and mycological cure assessed at 12 weeks and 24 weeks. Secondary outcomes will include reduction in nail thickness, improvement in nail appearance, patient satisfaction, recurrence rate, and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria Age between 18 to 75 years.
- •Involvement of two or more fingernails or toenails.
- •Positive KOH microscopy for fungal elements.
- •Treatment-naïve patients (no prior antifungal treatment for onychomycosis).
排除标准
- •Age below 18 years.
- •Involvement of less than two fingernails or toenails.
- •Negative KOH mount for fungal elements.
- •Female subjects who are pregnant, nursing, or planning to become pregnant during the study period.
- •Presence of other conditions causing nail dystrophy such as psoriasis, eczema, lichen planus, or immunodeficiency states (e.g., HIV infection, post-organ transplantation, long-term immunosuppressive therapy, chemotherapy, or radiotherapy).
- •Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), or immune systems, or other medical conditions which may interfere with or confound study assessments (e.g., pre-existing chronic foot pain, neurologic deficit, or skin disease/injury of the treated foot).
结局指标
主要结局
Clinical cure – improvement in nail appearance, reduction in discoloration and thickness, assessed at 12 weeks and 24 weeks.
时间窗: 12 AND 24 WEEKS POST INITIATION OF TREATMENT
Mycological cure – negative KOH microscopy and culture at 12 weeks and 24 weeks.
时间窗: 12 AND 24 WEEKS POST INITIATION OF TREATMENT
次要结局
- To evaluate patient-reported outcomes including pain, discomfort, and cosmetic(improvement.)
研究者
Ankush Kumar Somvanshi
Institute Of Naval Medicine, INHS Asvini