NCT00257530已完成3 期
Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Drugs for Neglected Diseases2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to healing
研究概览
简要总结
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
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
- Double
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/Females between 5 and 65 yrs
- •CL diagnosis confirmed
- •>4 weeks time disease
- •no prior anti-leishmanial therapy for CL
- •negative pregnancy test
- •informed written consent or parent consent for <18yrs patients
排除标准
- •>25cm2 lesion(s)
- •>6 cutaneous lesions
- •mucosal lesion
- •previous exposure to Imiquimod or anti-leish treatment
- •participation in another protocol within 30 days prior study
- •other acute or chronic illness / medication that may interfere
- •significant psychiatric illness
- •anaphylaxis or severe allergic reaction to proposed drugs
- •patients unlikely to cooperate
- •concomitant infection
- •pregnancy or breast feeding
结局指标
主要结局
Time to healing
Reduction of scaring
次要结局
- Safety (measured by AE reporting) during treatment and follow up to 12 months
研究者
研究点 (2)
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