WR279,396, a Third Generation Aminoglycoside Ointment for the Treatment of Leishmania major Cutaneous Leishmaniasis: A Phase 2, Randomized, Double Blind, Placebo Controlled Study

Cutaneous leishmaniasis is due to a small parasite (Leishmania) that creates disfiguring sores, and affects more than one million persons (mainly children) each year. Treating lesions with a cream—instead of with injections as currently done—would greatly improve the well-being of affected patients. No cream formulation that would be efficient and would not create important skin irritation has been identified yet. Here, we tested a new cream formulation (WR279,396) containing paromomycin and gentamicin, two members of a well-known family of antibacterial antibiotics (aminoglycosides). Injectable paromomycin is efficient in other forms of the disease (visceral leishmaniasis). This was a carefully monitored study (phase 2) involving mainly children in Tunisia and France. The cream was applied twice a day for 20 days. The proportion of patients treated with the paromomycin-containing cream (active formulation) that cured (94%) was higher than that observed (71%) in patients treated with a cream that did not contain the active product (placebo formulation). Local irritation affected less than one-third of the patients and was usually mild. This new cream formulation was safe and effective in treating cutaneous leishmaniasis, thereby providing a new, simple, easily applicable, and inexpensive treatment for this neglected disease

Healing of old world cutaneous leishmaniasis in travelers treated with fluconazole: Drug effect or spontaneous evolution?

International audienceThe efficacy of fluconazole was evaluated in 35 travelers with parasitologically proven imported Old World cutaneous leishmaniasis (CL). Leishmania major (mainly MON-25) was identified in 15 patients and strongly suspected given the transmission area in 12 of these patients. Daily oral fluconazole (200 mg/day for adults and 2.5 mg/kg/day for children) was prescribed for six weeks. Outcome definition was based on re-epithelialization rate at day 50. Of the 27 L. major-infected patients, 12 (44.4%) were cured. This cure rate is similar to the placebo cure rate from trials in L. major CL in which, as in the present report, the definition of outcome relied exclusively on re-epithelialization. These data question the assumption that oral fluconazole is consistently effective for treatment of CL caused by L. major