A Comparative study to evaluate Efficacy and Safety of Topical Permethrin versus Oral Ivermectin in patients with scabies at a tertiary care centre: A Randomised controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Efficacy will be assessed by :
研究概览
简要总结
Need for study:
Uncomplicated scabies is a skin disease caused by ectoparasite sarcoptes scabiei var. hominis without crusting, secondary infections and its consequences.It is contagious and most usually seen in congested populations with inadequate cleanliness, spreading swiftly from one person in close touch to another.1 The estimated global prevalence ranges from 0.2 to 71%, affecting over 300 million individuals each year.2 In India, the prevalence ranges from 13% to 59% in both rural and urban areas.
Direct contact between individuals occurs when mites crawl on the surface of the skin and develop burrows. Uncomplicated scabies symptoms include itching, skin rashes, and lesions.3 The most common is severe itching, which is usually worse at night. Lesions are slightly elevated brownish tortuous lesions that often appear in the finger webs, flexor surfaces of the wrists, elbows, axillae, buttocks, genitalia, and female breasts.3 Scabies medicines include benzyl benzoate, permethrin ointment, ivermectin cream, lindane, and crotamiton. Ivermectin, taken orally, is the only medicine used to treat ectoparasitosis and is extremely effective against scabies.4
Many people believe that topical permethrin is the medicine of choice right now. For individuals who cannot tolerate or are non-adherent to topical medication, oral Ivermectin is usually preferable. Considering the paucity of comparative studies on efficacy and safety of topical permethrin versus oral ivermectin in uncomplicated scabies amongst Indian patients, this study is being undertaken to compare the therapeutic efficacy and safety of topical permethrin versus oral ivermectin in patients with uncomplicated scabies.3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written informed consent
- •Patients of either sex aged 18 to 60 years
- •Patients diagnosed with uncomplicated scabies.
排除标准
- •Patients with crusted scabies, secondary infections and its consequences like skin sores, septicemia, heart disease, chronic kidney disease.
- •Patients with history of epileptic fits, immunodeficiency and any other coexisting skin disease that could interfere with treatment evaluation.
- •Pregnant and lactating mothers
- •In addition, patients with history of known hypersensitivity to Ivermectin.
- •Psychiatric/ emotional disturbance in patients which could limit ability of patients to comply.
结局指标
主要结局
Efficacy will be assessed by :
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
Clinical improvement in signs and symptoms such as,
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
1.Measuring reduction in the Pruritus with skin rash at week 1 and 2
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
Safety will be assessed by:
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
Number and severity of adverse events.
时间窗: Efficacy will be assessed by : | Clinical improvement in signs and symptoms such as, | 1.Measuring reduction in the Pruritus with skin rash at week 1 and 2 | 2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2 | Safety will be assessed by: | Number and severity of adverse events.
次要结局
未报告次要终点
研究者
Anitha
Bangalore medical college and research institute bangalore