Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .
研究概览
简要总结
Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.
详细描述
- Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.
- Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.
Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.
Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.
Study will be conducted over a period of 6-8 months.
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
- Single (Participant)
盲法说明
Participants will be randomly assigned to group one or two.
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.
排除标准
- •individuals with two or more co-morbidities or known cases of chronic liver disease.
研究组 & 干预措施
Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin
This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections.
干预措施: Terbinafine Pill (Drug)
Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin
This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections
干预措施: Itraconazole capsule (Drug)
结局指标
主要结局
Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .
时间窗: 2-4 weeks
Classical clinical features of dermatophyte skin infections (pruritis, erythema and scaling, all will be graded on a scale 0-3 i. e 0=none to 3=severe) would be noted at start of treatment after 2 weeks and then if required after 4 weeks of treatment.
Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.
时间窗: 2-4 weeks
Objective Assessment of adverse effects (nausea, vomiting, jaundice) as well as laboratory evaluation of liver function tests (Bilirubin umol/L, ALT U/L, ALP U/L) would be performed at start of treatment after 2 weeks and if required than after 4 weeks.
次要结局
- Duration of treatment required to achieve cure from resistant dermatophyte infections.(2-4 weeks)
研究者
Dr. Umar Abdul Ali Qureshi
Speciality Registrar Dermatology
Pak Emirates Military Hospital