Comparison of Permethrin-Based Treatment Strategies Against Scabies in Infants and Young Children
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Treatment of scabies
研究概览
简要总结
To compare the efficacy of different permethrin-based therapies for scabies infestations in infants and young children.
详细描述
Globally, Scabies infects 300 million people each year and among children of developing countries, its prevalence is estimated to be about 5-10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males are more prone to infestation than females, and early school- aged children are the most vulnerable as it is usually transmitted by prolonged skin-skin contact.
It was more widespread in urban than in rural areas with a distinct seasonal pattern, with the biggest infestation occurring in the winter and the lowest in the summer with all risk factors accounting for 89% of the variation in its prevalence.The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching with a predilection for fingers, axilla, elbows, waist, belly, groin, genital area, etc. Several antiscabietic treatment options exist, including topically applied permethrin, benzyl benzoate (BB) and crotamiton, and oral ivermectin.5 Repeated administration of topical permethrin 5%, topical BB 10-25% or systemic ivermectin dosed at 200 μg/kg body weight is currently recommended as first-line treatment by the 2017 European guidelines for the management of scabies.Permethrin, a synthetic pyrethroid with scabicidal and ovicidal activity, disrupts the function of the voltage-gated sodium channels in the neuronal membrane of the mites, resulting in paralysis and death. Permethrin is highly effective against scabies and well- tolerated without major side-effects, as it is minimally absorbed through the skin and rapidly eliminated, thus exerting minimal systemic presence in humans.Hence, it is recommended as a first-line therapy for adults and children in many countries
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
- 1 Month 至 4 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 month to 4 years age.
- •Both gender
- •Scabies as defined in operational definition
排除标准
- •• Drug sensitivity test results for hypersensitivity to permethrin
- •Having renal or hepatic impairment.
- •Individuals with additional long-term skin and systemic disorders (such as diabetes, hypertension, asthma, epilepsy, acne, psoriasis)
研究组 & 干预措施
Standard permethrin treatment
Standard permethrin treatment
干预措施: Permethrin 5% (Drug)
Intensified permethrin treatment
Intensified permethrin treatment
干预措施: Permethrin 5% (Drug)
结局指标
主要结局
Treatment of scabies
时间窗: 15 days
For efficacy, we will see microscopy (presence of any one by examine skin scraping under a microscope for mites(eyeless and spherical in shape with eight legs parasite)/eggs (oval shape).The absence of these will be considered significant.
次要结局
- Scabies(15 days)
研究者
Shanza zafar
Doctor
Pak Emirates Military Hospital
