2024-520348-40-00招募中4 期
A Comparative Trial on Scabies Treatments: Topical Permethrin, Oral Ivermectin and Combination of Topical Permethrin and Oral Ivermectin
Giuliani S.p.A.3 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年7月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)
研究概览
简要总结
To compare the clinical cure rate (CCR) of standard treatments of scabies (topical permethrin 5% vs. oral ivermectin or their combination) in the short-term clinical cure rate. A superiority trial.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female aged >18 years and <80 years
- •Presence of uncomplicated scabies confirmed by dermatological evaluation and a positive scraping test demonstrating the presence of Sarcoptes Scabiei mites, their eggs or faecal pellets (scybala). If the patient has positive result it is recommended to also visit the cohabitants to whom to propose the study in case they are positive
- •Immunocompetent
- •Giving informed written consent to participate to the trial
排除标准
- •Subjects with crusted scabies
- •Subjects HIV positive
- •Antiscabietic treatments in the previous 4 weeks before entry into the study
- •Pregnancy or breastfeeding
- •Medical History with hepatic, cardiac or renal diseases
- •Participant must not be simultaneously enrolled in any interventional clinical trial
- •Women with childbearing potential if they do not agree with the use of highly effective contraceptive methods with low user dependency, or to be abstinent from heterosexual intercourse
结局指标
主要结局
Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)
Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)
次要结局
- Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 2 (week 2)
- Percentage of Subjects with score 0 or 1 at week 1
- Percentage of subjects with CCR at week 2
- Percentage of subjects with score 0 or 1 at week 2
- Subjective evaluation of itching at week 1 and 2
- Percentage of treatment failure at week 1 and week 2 (treatment failure is defined as: no improvement at all of itching intensity and skin lesions count and/or appearance of new lesions)
- Safety and Tolerability endpoints: (at week 1, week 2) - Evaluation and recording of spontaneous reported adverse events - Blood pressure monitoring - Heart rate
研究者
Daniela Pinto
Scientific
Giuliani S.p.A.
研究点 (3)
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