Studio Nazionale Sull'Epidemiologia ed Efficacia Delle Terapie Nel Trattamento Della Scabbia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,332
- 试验地点
- 1
- 主要终点
- Healing Rate
研究概览
简要总结
Multicentre retrospective, prospective, non-profit, national observational study
详细描述
Scabies is an infectious skin condition caused by the mite Sarcoptes scabiei var. hominis. This mite can only parasitise and reproduce in the outermost layer of human skin (the stratum corneum). The disease is typically transmitted through human-to-human contact, though it can also be transmitted through fomites. It affects between 200 and 300 million people worldwide each year, with considerable variation in prevalence ranging from 0.2% to 71.4% in different regions. Over the past 10-20 years, the frequency of epidemics appears to be increasing, not only in countries where scabies is prevalent, but also in states that have historically experienced low rates of infection.The increase in cases across Europe, coupled with the rapid epidemic spread of the disease and the emergence of resistance to topical treatments, underscores the imperative for a comprehensive and systematic study involving multiple centres.
The primary guidelines for managing scabies involve performing environmental hygiene measures, such as washing and changing clothing daily and cleaning all surfaces that come into contact with the skin.
In terms of treatment, the European Society of Dermatology and Venereology guidelines recommend topical permethrin or benzyl benzoate and oral ivermectin as first-line treatments.
Apply topical permethrin 5% cream in the evening to cool, dry skin all over your body, including the folds, navel, limbs, genitals, the area behind your ears and under your nails. If there are any suspicious lesions, the scalp and face should also be treated, avoiding the areas around the eyes and lips. Leave the cream in place for 8-12 hours and apply a second dose after 7-14 days.
Oral ivermectin should be taken as a single dose at a dosage of 200 μg/kg, repeated in the same manner after seven days. Although European guidelines recommend taking it on a full stomach, the manufacturer and other guidelines recommend taking it on an empty stomach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age with clinical and/or dermoscopic and/or microscopic diagnosis of scabies.
- •Close contacts (household/relatives) of patients diagnosed with scabies.
- •Obtaining informed consent.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Healing Rate
时间窗: From the date of enrolment until the date of healing, assessed up to 52 weeks.
The cure rate is represented by the number of patients who were cured after the first treatment.
次要结局
- Frequency of scabies diagnosis(From the date of enrolment to the previous three years)
- Epidemiological analyses(at the end of the study)
- body distribution(Baseline)
- presence/absence of clinical parameters(Baseline)
- presence/absence of language barriers(Baseline)