PACTR202205775486864尚未招募3 期
‘A PHASE II/ III, OPEN LABEL, MULTICENTRE, RANDOMISED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THERMOTHERAPY FOR THE TREATMENT OF UNCOMPLICATED CUTANEOUS LEISHMANIASIS CASES’
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •·Males and females, aged =18 and =60 years old.
- •·Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods:
- •1) Microscopic identification of amastigotes in stained lesion tissue, or
- •2) Demonstration of Leishmania by Polymerase Chain Reaction (PCR), or
- •3) Positive by NNN culture for promastigotes.
- •Patient who has a lesion that satisfies the following criteria:
- •-Lesion size less than 4 cm (longest diameter).
- •-Not located on the ear, face, close to mucosal membranes, or on a location that in the opinion of the Principal Investigator (PI) is difficult to apply either intervention.
- •-Patient with less than 4 CL lesions.
- •-Duration of lesion less than 6 months by patient history.
- •·Patient able to give written informed consent.
- •In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
排除标准
- •Females with a positive urine pregnancy test at screening and/or who do not agree to take contraception until end of treatment.
- •Prior topical treatment failure (including SSG-IL and/or cryotherapy)
- •Receiving a conventional treatment or traditional remedy against CL within 2 months of enrolment into the study
- •Any condition that prevents the patient from following the study treatment and/or the follow-up
研究者
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