Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama

Abstract

In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis.

Topical Paromomycin and Gentamicin for New World Cutaneous Leishmaniasis in Panama

“…The cure rates in these two studies were similar to those seen by Sosa and others1 with combination therapy (86%). Thus, good cure rates for L. panamensis NWCL can be obtained when paromomycin ointment is combined with other agents.…”

“…Finally, we would like to mention that Sosa and others1 assert that their entry criteria of < 10 cutaneous lesions and no evidence of systemic dissemination conferred a very low risk for future mucosal infection. However, other authors consider local therapy for NWCL caused by L. braziliensis and L. panamensis unsuitable because of the potential risk of metastasis or secondary mucosal spread, and local therapy is recommended only for patients with ≤ 4–5 lesions 6,7…”

Annihilation of Leishmania by daylight responsive ZnO nanoparticles: a temporal relationship of reactive oxygen species-induced lipid and protein oxidation

“…Leishmaniasis is still one of the major infectious diseases worldwide with a serious risk to 350 million people in 98 countries and ~2 million new cases reported every year. 9 Leishmania tropica is mainly responsible for cutaneous leishmaniasis and the parasite is capable of producing single or multiple ulcers at the biting place. 10 Photodynamic therapy (PDT) used for the treatment of cancer and infectious diseases has emerged as a noninvasive medical technology.…”

An update on pharmacotherapy for leishmaniasis

“…142 In a recent Phase 2 trial of 30 patients with L. panamensis CL, once daily topical treatment with WR 279,396 or paromomycin alone (15% paromomycin) for 20 days had a cure rate after 6 months of 87% for WR 279,396 and 60% for paromomycin alone. 143 A combination of topical paromomycin–methylbenzethonium chloride and injectable meglumine antimoniate in a shortcourse treatment of 7 days in Colombia with a higher proportion of L. panamensis infections resulted in cure rates of 90 %. 144 While another study in Columbia with L. panamensis and L. brasiliensis this combination did not improve the cure rates.…”