Double-blind, Randomized, Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Peru

Oficina del Cirujano General, Departamento del Ejercito de Estados Unidos,0 个研究点目标入组 30 人开始时间: 2009年3月9日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

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: 5 至 65（—）
性别: All

入选标准

•The patient is male or female older than or equal to 5 years of age
•The patient or legal guardian is in a position to give informed consent or written consent, as appropriate
•The patient has a diagnosis of LC in at least one lesion detected by one of the following methods: I) positive culture of promastigotes or 2) microscopic identification of amastigotes in the smear of the lesion
•The patient has at least one ulcer lesion> I cm and <5 cm, which meets the criteria of an index lesion
•The patient is willing to undergo other forms of treatment for LC, including other investigative treatments during the study
•In the opinion of the investigator, the patient (or his legal guardian) is able to understand and comply with the protocol
•If she is a woman of reproductive age, the patient presented a negative serum pregnancy test during the selection and agreed to use an acceptable method of birth control during the treatment phase and for one month after the end of the treatment.
•The patient has adequate venous access for blood draws

排除标准

•The patient has only one lesion whose characteristics include any of the following: warty or nodular lesion (non-ulcer) lesion <1 cm in greatest diameter, lesion located in a place where, in the opinion of the researcher, it is difficult to maintain topical application of study medications
•The patient has an injury caused by leishmania that includes the mucosa or palate
•The patient has signs and symptoms of disseminated disease according to the opinion of the principal investigator
•The patient has> 10 lesions
•The patient is a woman who is breastfeeding
•The patient has an active neoplasm or has a history of removal of a solid, metastatic or hematologic tumor with the exception of basal cell carcinoma or squamous cell skin
•The patient has a significant organic abnormality, a chronic disease such as diabetes, severe hearing loss, evidence of liver or kidney dysfunction, or levels of creatinine, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) beyond 15% above of the Upper Normal Limit (LSN) according to the definition of the normal ranges of the clinical laboratory
•The patient was treated for leishmaniasis with a medication with pentavalent antimony, such as sodium stibogluconate (Pemostam): meglumine antimony agent (Glucantime); amphotericin B (includes amphotericin B Uposomal and amphotericin B deoxycholate); WR 279396: or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin: fluconazole; ketoconazole; pentarrudina; miltefosinc: azithromycin or allopurinol within 8 weeks prior to beginning study treatments
•The patient has a history of confirmed diagnosis or suspected hypersensitivity or idiosyncratic reactions to the amynoglycosides
•The patient has another topical disease / condition that could interfere with the objectives of this study.

研究者

发起方

Oficina del Cirujano General, Departamento del Ejercito de Estados Unidos,

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