Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- monitoring for reduction in size of scaling weekly for 8 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if topical amphotericin b solution works to treat resistant cases of tinea capitis in children. It will also learn about the safety of drug. The main questions it aims to answer are:
Does amphotericin b solution effective in cases not cured by systemic antifungal tab?
Participants will:
use topical amphotericin b solution every day for8 weeks Visit the clinic once every 1 week for follow up then follow up after 1 month and fungal culture will be done to test if the treatment working
详细描述
The aim of the study will be to evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment .
Patient and method After approval of the study by Research and Ethical committee at Sohag faculty of medicine, this study will include group of patients attending the outpatient clinic of Dermatology, venereology and andrology department in Sohag university hospital.
An informed written consent will be obtained from parents of all participants after full explanation of the procedure.
Inclusion criteria:
Children aged < 16 years affected by tinea capitis non inflammatory type who are clinically and dermoscopically confirmed after resistant response to oral systemic treatment for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged < 16 years affected by tinea capitis non inflammatory type who are clinically and dermoscopically confirmed after resistant response to oral systemic treatment for 8 weeks.
排除标准
- •Patients with inflammatory tinea capitis, kerion or favus. Patients with known hypersensitivity to amphotericin B, other systemic conditions or ongoing use of conflicting medications.
研究组 & 干预措施
amphotericin b topical solution
evaluate the efficacy and safety of topical amphotericin B solution in treatment of non-inflammatory type of tinea capitis after resistant response to oral systemic treatment .
干预措施: Amphotericine in liposome (Ambisome®) (Drug)
结局指标
主要结局
monitoring for reduction in size of scaling weekly for 8 weeks
时间窗: 4 months
• children 16 years old or less will be evaluated to detect an effect size of 0.3 in the rate of the disease improvement (reduction in scaling) on repeated measurements (follow up weekly for 8 weeks)
次要结局
未报告次要终点
研究者
Zainab Alkassem Nour
Principal Investigator
Sohag University