Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT01494350
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Subject has a 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) positive culture for promastigotes.
* Subject has a parasitologically confirmed lesion that satisfies the following criteria for an Index lesion:
* ulcerative in character
* lesion size ≥ 1 cm and ≤5 cm (including the area of induration surrounding the lesion)
* not located on the ear, or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
* Subject has \< 7 leishmaniasis total lesions.
* Subject is willing to forego other forms of treatments for CL including other investigational treatments during the study.
* In the opinion of the investigator, the subject (or their legal guardian) is capable of understanding and complying with the protocol.
Exclusion Criteria:
* Female with a positive serum pregnancy test or who is breast feeding.
* History of clinically significant medical problems in the investigator's judgment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
* Age adjusted blood creatinine or blood urea nitrogen (BUN) levels indicative of clinically significant renal disease or aspartate amino transferase (AST), alanine amino transferase (ALT), or total bilirubin that suggest clinically significant hepatic impairment as judged by the PI or subinvestigator. Note: This study is designed to evaluate populations who may have some renal or hepatic dysfunction as the drug has not been shown to have serum levels that would be expected to show renal or hepatic toxicity and treatment of the general population presenting with CL is highly desired based on its safety profile compared to other leishmanial drugs.
* Evidence of disseminated leishmaniasis.
* Received treatment for leishmaniasis with antimonials or any medication likely, in the opinion of the PI, to modify the course of the Leishmania infection within 56 days of starting study treatments.
* History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01494350
Study Brief:
Protocol Section:
NCT01494350