Effectiveness of Ciprofloxacin Intralesional Injection in the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate: a Parallel Groups Comparative Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection.
In a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis
排除标准
- •Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study
- •patients on prolonged corticosteroid therapy.
研究组 & 干预措施
intralesional ciprofloxacin
Intralesional ciprofloxacin (2 mg/ml, 100 ml, Ciproxin®, Bayer Schering pharma AG, Germany), each lesion was injected based on lesion size (2 mg/cm2). The infiltration of intralesional dose was given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients were only asked to come for lesion assessment. A fine insulin needle was used to infiltrate the lesion.
The lesion was thoroughly infiltrated with the drug solution until the base was completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia was added. The solutions were injected intralesionally and not subcutaneously.
干预措施: Ciprofloxacin (BAYO9867) (Drug)
intralesional sodium stibogluconate
Intralesional sodium stibogluconate (100 mg/ml, 100 ml vial, Pentostam®, GlaxoSmithKline, UK), each lesion was injected based on lesion size (1 mg/cm2).
The infiltration of intralesional dose was given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients were only asked to come for lesion assessment. A fine insulin needle was used to infiltrate the lesion.
The lesion was thoroughly infiltrated with the drug solution until the base was completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia was added. The solutions were injected intralesionally and not subcutaneously.
干预措施: sodium stibogluconate (Pentostam) (Drug)
结局指标
主要结局
Cure rate
时间窗: From enrollment to the end of treatment up to 90 days.
Patients were followed weekly up to 90 days after the first injection; four parameters were used for assessment as follows according to Sharquie modified leishmania score: 1. Measure the size of the lesion through the surface area 2. Measurement of the induration of the lesion 3. Assess the degree of erythema of the lesion 4. Assess the presence and absence of ulceration The obtained data is converted from numbers into scores. The total score was calculated by adding individual scores. Score 13-16: Mild response. Score 9-12: Moderate response. Score 5-8: Marked response. Score 0-4: Complete response \& clearance Both marked and complete responses are considered as a cure
次要结局
未报告次要终点
研究者
Hayder Adnan Fawzi
Ass Prof
Al-Mustafa University College