Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis

NO_LONGER_AVAILABLE

Conditions studied: Leishmaniasis, Cutaneous

In brief

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.

Key facts

Study ID

NCT01641796

Run by

U.S. Army Medical Research and Development Command

Last updated by the study team

2020-05-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Clinically significant concomitant disease that would preclude the patient from completing treatment in the opinion of the treating physician.
• Clinical Evidence of mucosal involvement
• Known allergy to aminoglycosides
• Females who are pregnant or breastfeeding

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Military Treatment Facilities — Multiple Locations, Maryland, United States

Full record on ClinicalTrials.gov

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