Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Complete healing of the lesion(s)
研究概览
简要总结
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.
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
- Single
入排标准
- 年龄范围
- 9 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parasitologically proven cases of CL based on positive smear and/or culture
- •Otherwise healthy subjects on the basis of medical history.
- •Age 9-70 years
- •Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
排除标准
- •Pregnant or lactating women
- •Duration of lesion more than 6 months
- •Number of lesions more than 4
- •History of allergy to Glucantime
- •Serious systemic illnesses (as judged by the physician)
- •Participation in any drug trials in the last 60 days
- •No indication for systemic treatment
研究组 & 干预措施
1
Intra-lesional injection of Glucantime once a week
干预措施: Meglumine antimoniate (Drug)
2
Intra-lesional injection twice a week, 0.1/cm2
干预措施: Meglumine antimoniate (Drug)
结局指标
主要结局
Complete healing of the lesion(s)
时间窗: 5 months
次要结局
- Partiall cure(5 months)