The Efficacy and Tolerability of Itraconazole oral solution in Paediatric Dermatophytosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Efficacy of Oral Itraconasole solution in Paediatric age group
研究概览
简要总结
Purpose of Trial
Presently dermatophytosis in India is resistant to treat and itraconazole is the widely used drug for the management considering the low response rate for previously used drugs like terbinafine, fluconazole and griseofulvin. Even though dermatophytosis in children is rare compared to adults, in the present epidemic it is seen in children also and the management of these recurrent and resistant dermatophytosis is a therapeutic challenge.
Even though itraconazole in capsule form is widely used, it is difficult to administer it in children considering the size of the capsule. In view of the recent availability of itraconazole oral solution, this can be effectively administered with ease in children. However, there are only a few studies in the literature for the treatment of dermatophytosis with oral Itraconazole solution, hence this study is conducted.
Itraconazole oral solution is efficacious and tolerable in Paediatric Dermatophytosis.
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients age group of 1to12 years with clinical diagnosis of cutaneous dermatophytosis in glabrous skin (Tinea faciei, Tinea corporis and Tinea Cruris).
- •Both boys and girls will be included in the study.
- •Patients /parents/guardians who are consenting to participate in the study.
- •Patients with recurrent and extensive (10% body surface area) Tinea infection will be taken for the study.
排除标准
- •â€¢Patients with other pre-existing skin disorders.
- •â€¢Patients/parents/guardians who are not willing to participate in the study.
结局指标
主要结局
Safety and Efficacy of Oral Itraconasole solution in Paediatric age group
时间窗: Two weeks and Four weeks
次要结局
- Tolerability and side effects of oral itraconazole solution(2 weeks and 4 weeks)