Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Complete re-epithelization
研究概览
简要总结
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
详细描述
Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.
Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
- •1 to 5 lesions
- •Signed informed consent
排除标准
- •Facial lesions
- •Significant co-morbidity
- •Pregnancy or breast-feeding at enrollment
- •Previous treatment for leishmaniasis
研究组 & 干预措施
AM-B
Topical Amphotericin-B 0.4% liposomal gel
干预措施: Topical Amphotericin-B 0.4% liposomal gel (Drug)
Placebo
Placebo gel preparation
干预措施: Topical Amphotericin-B 0.4% liposomal gel (Drug)
结局指标
主要结局
Complete re-epithelization
时间窗: Day 28 from enrollement
Absence of ulceration, induration, erosion and
次要结局
- Lesion size(Day 28 and day 56 from enrollement)
- Complete re-epithelization(Day 28 from enrollement)
- Skin manifestations(Day 28 and day 56 from enrollement)
- Evidence of lesihmania infection(Day 56 from enrollement)
研究者
AMIR HOREV
Head, Pediatric dermatology Service, Soroka University Medical Center
Soroka University Medical Center