Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis
This is an expanded access treatment protocol designed to provide a topical cream treatment option to military health care beneficiaries with parasitologically confirmed uncomplicated Cutaneous Leishmaniasis.
• Male or female military health care beneficiary of any age.
• Diagnosis of uncomplicated CL by having at least one lesion parasitologically confirmed by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue; and/or 3) PCR assay performed either at the LDL, WRAIR or the Clinical Parasitology Service, CDC.
• Ability to comprehend and willingness to sign informed consent or give assent
• CL lesions in a location amenable to topical treatment
• Patient is willing to forgo other treatments for CL while on treatment program
• Females of childbearing potential must have a negative pregnancy test within 1 day of starting treatment and agree to use an acceptable method of birth control from start of treatment until 2 weeks after completing treatment