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临床试验/NCT07247630
NCT07247630尚未招募1 期

Comparison of Permethrin-Based Treatment Strategies Against Scabies in Infants and Young Children

College of Physicians and Surgeons Pakistan1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年1月15日最近更新:
适应症
干预措施

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

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

Active Comparator

Standard permethrin treatment

干预措施: Permethrin 5% (Drug)

Intensified permethrin treatment

Active Comparator

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

发起方
College of Physicians and Surgeons Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shanza zafar

Doctor

Pak Emirates Military Hospital

研究点 (1)

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