Comparison Between Therapeutic Efficacy of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Pediatric Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Fungus eradication
研究概览
简要总结
Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in children with tinea capitis.
详细描述
The existing literature carries varying results between the effectiveness of itraconazole pulse therapy and continuous terbinafine therapy in treating tinea capitis, and local data in this regard is also scarce. The findings of this study would not only add to the statistics but would also help clinicians to offer a treatment modality in pediatric tinea capitis, which should have better efficacy, a low incidence of side effects, and better patient compliance.
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
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 1-13 years
- •With KOH mount positive before start of treatment
- •Duration of disease more than 1 month
排除标准
- •KOH mount negative before starting the treatment
- •Topical treatment with antifungal agents within past 4 weeks
- •Systemic treatment with antifungal agents within past 4 weeks
- •Patients with active liver disease
- •Patients with elevated liver enzymes
研究组 & 干预措施
Terbinafine group
Patients will be given terbinafine in a dose of 62.5 mg for less than 20 kg body weight, 125 mg from 20 to 40 kg, and 250 mg for more than 40 kg for a period of 4 weeks.
干预措施: Terbinafine (Drug)
Itraconazole group
Patients will receive itraconazole a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients of this group.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Fungus eradication
时间窗: 9 weeks
Treatment will be labeled efficacious if the patient will be cured clinically as well as mycologically, i.e., samples treated with KOH will show no fungal elements.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research