Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- scar appearance
研究概览
简要总结
The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.
Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.
详细描述
20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited.
Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam.
Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Objective cutaneous leishmaniasis diagnosis.
- •More than one Lesion
排除标准
- •Previous treatment
- •Abnormal scarring
研究组 & 干预措施
Treatment
CO2 fractional laser with local application of Pentostam
干预措施: fractional CO2 laser (Device)
Treatment
CO2 fractional laser with local application of Pentostam
干预措施: Local application pentostam (Drug)
control
Intra-lesinal Pentostam injedction
干预措施: intra-lisional pentostam (Drug)
结局指标
主要结局
scar appearance
时间窗: At sixth month
Each lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome
次要结局
- Pain assessed by VAS(at one month, two months, and three months)