Topical antibiotic clears cutaneous leishmaniasis

February 11, 2013

An investigational topical cream composed of two antibiotics effectively treated cutaneous leishmaniasis, results of a phase 3 study demonstrated.

 

An investigational topical cream composed of two antibiotics effectively treated cutaneous leishmaniasis, results of a phase 3 study demonstrated.

Investigators from Walter Reed Army Institute of Research evaluated the cream - WR 279,396, which was composed of paromomycin 15 percent and gentamicin 0.5 percent - in patients who had one to five ulcerative lesions from cutaneous leishmaniasis, according to the study abstract. The 375 patients enrolled in the study were randomly assigned to receive the cream, gentamicin alone or vehicle control.

Investigators treated each lesion once daily for 20 days. A “cure” was defined as a reduction in the size of the lesion by at least 50 percent by 42, complete re-epithelialization at 98 days and absence of relapse at the conclusion of the trial, 168 days.

Those receiving the combination topical treatment had a cure rate of 81 percent, while 58 percent of those receiving placebo were cured. Patients who received paromomycin alone had a cure rate of 82 percent.

Treatments currently available for cutaneous leishmaniasis include antimonial salts that are administered intravenously or are injected directly into the lesion. The condition affects 1.5 million people worldwide annually, and is most common in developing nations and in children.

The Food and Drug Administration designated the investigational topical cream as eligible for fast-track review, according to a news release, as cutaneous leishmaniasis is considered a “neglected disease.”

The study was published Feb. 7 in the New England Journal of Medicine.