Efficacy and Safety of Terbinafine and Itraconazole Monotherapy in Conventional and Increased Doses and in Combination in Dermatophytosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Achievement of mycological cure at 2 weeks
研究概览
简要总结
There is a rise in the prevalence in recent years especially in tropical countries along with an increase in the number of treatment failures with chronic and recurrent dermatophytosis. There is a huge gap between the treatment required in the present scenario and the treatment guidelines given in the standard books. The aim of the study is to determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of dermatophytosis. The study design will be a randomized parallel-group trial. Patients will be randomly divided into five parallel arms in which two of the standard drugs in recommended doses will be compared with their double doses and with a combination of both drugs. The patients will be reevaluated at 2, 4, 6, and 8 weeks of treatment (the end of therapy), using the physician Global Assessment (PGA) Scale. The cure will be considered a complete clinical resolution of the lesions. The patient's response to the treatment will be recorded. Safety and patient compliance will be recorded at each follow-up visit. Findings of observation will be recorded on a pre-prescribed and pre-tested data collection form. After collection, all data will be checked and compiled. Data will be processed and analyzed using computer software with statistical packages for social science SPSS-26. An analysis plan will be developed keeping in view the objectives of the study. The results of the continuous measurement will be presented on mean ± SD (mean-max) and results on categorical measurements will be presented in numbers (%). A p<0.05 will be considered statistically significant. Results will be disseminated to all Dermatology departments in Bangladesh.
详细描述
Dermatophyte infections are common fungal infections aggravated by hot and humid climates. Unprecedented changes in the epidemiology, clinical features, and treatment responsiveness of dermatophyte infections have been noted in the recent past in Bangladesh, with many patients presenting with treatment failure and chronic relapsing tinea. Terbinafine and itraconazole are commonly used oral antifungal agents for the same. There is a paucity of original studies especially in Bangladesh depicting dermatophytosis becoming a huge menace both to the patient and to the treating physician. Terbinafine is a fungicidal drug and acts by inhibiting the enzyme squalene epoxidase which converts squalene to lanosterol. Itraconazole is basically a fungistatic drug that acts through the inhibition of the enzyme 14α-demethylase. Many dermatologists have started using higher doses and combination regimens of antifungals to counter this problem. However, such regimens have not been validated. Therefore, this study is designed to evaluate the efficacy of terbinafine and itraconazole in conventional and increased dosages and in combination in the treatment of tinea corporis, tinea cruris, and tinea faciei.
Objectives:
- General: To evaluate the efficacy and safety of terbinafine and itraconazole in conventional and increased doses and in combination with dermatophytosis patients attending the outpatient department of Dermatology and Venereology in Dhaka Medical College Hospital.
- Specific:
- To evaluate the efficacy and safety of terbinafine in conventional and increased doses in dermatophytosis patients attending at the outpatient department of Dermatology and Venereology in Dhaka Medical College Hospital.
- To evaluate the efficacy and safety of itraconazole in conventional and increased doses in dermatophytosis patients attending at the outpatient department of Dermatology and Venereology in Dhaka Medical College Hospital.
- To evaluate the efficacy and safety of terbinafine and itraconazole in combination with dermatophytosis patients attending at the outpatient department of Dermatology and Venereology in Dhaka Medical College Hospital.
- To observe the side effects of terbinafine and itraconazole in conventional and increased doses and in combination with dermatophytosis patients attending at the outpatient department of Dermatology and Venereology in Dhaka Medical College Hospital.
Methodology:
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of tinea corporis, tinea cruris or tinea faciei or any combination of these conditions
- •Microscopic confirmation of tinea (KOH microscopy showing regularly septate branching hyphae),
- •Age 18- 60 years
排除标准
- •Children less than 18 years of age
- •Pregnancy and lactation
- •Patients with co-existent tinea unguium, tinea pedis, or tinea manuum,
- •History of recent use of antifungal drugs or steroids in last 4 weeks.
- •Patient with any other disease requiring systemic therapy
- •Patients with co-morbidities like cardiac disorder, liver disorder, renal disorder
- •History of a drug reaction or allergy to any of the two drugs
- •Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT), and electrocardiogram (ECG),
- •Patients or attendants refused to give informed consent to take part in the study
研究组 & 干预措施
Group I1
Itraconazole 200 mg/day will be given in this group
干预措施: Itraconazole (Drug)
Group T+I
Terbinafine 250 mg + Itraconazole 200 mg/day will be given in this group
干预措施: Terbinafine Tablets (Drug)
Group T1
Terbinafine 250 mg/day will be given in this group
干预措施: Terbinafine Tablets (Drug)
Group T+I
Terbinafine 250 mg + Itraconazole 200 mg/day will be given in this group
干预措施: Itraconazole (Drug)
Group T2
Terbinafine 500 mg/day in two divided doses will be given in this group
干预措施: Terbinafine Tablets (Drug)
Group I2
Itraconazole 400 mg/day in two divided doses will be given in this group
干预措施: Itraconazole (Drug)
结局指标
主要结局
Achievement of mycological cure at 2 weeks
时间窗: 2 weeks
Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 2 weeks and will be noted as positive or negative.
Assessment of overall clinical symptoms with PGA
时间窗: At 8 weeks
The physician's global improvement(PGA) scale: The global improvement will be graded as grade I (1-25%), grade II (26-50%), grade III (51-75%), and grade IV (76-100%) improvement in overall clinical symptoms at the end of therapy at 8week.
Achievement of mycological cure at 8 weeks
时间窗: 8 weeks
Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 8 weeks and will be noted as positive or negative.
Achievement of mycological cure at 4 weeks
时间窗: 4 weeks
Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 4 weeks and will be noted as positive or negative.
Assessment of clinical parameters (itching, erythema, and scaling)
时间窗: 8 weeks
Patients will be evaluated for the severity of clinical parameters namely itching, erythema, and scaling using four-point scale as: 0 = none, l = mild, 2 = moderate, and 3 = severe. Erythema and scaling grade '0' and itching grade 0 or 1 will be considered as clinical cure.
Achievement of mycological cure at 6 weeks
时间窗: 6 weeks
Dermatophytes or yeast seen on a KOH test indicates the person has a fungal infection. The health care provider scrapes the problem area of your skin using a needle or scalpel blade. The scrapings from the skin are placed on a microscope slide. Liquid containing the chemical potassium hydroxide (KOH) is added. The slide is then examined under the microscope. A KOH examination will be done at 6 weeks and will be noted as positive or negative.
次要结局
- Assessment of treatment failure(8 weeks)
- Patient's Satisfaction with treatment(8 weeks)
研究者
Dr. Afsana Nahid
Assistant professor
Dhaka Medical College