Treatment for cutaneous leishmaniasis caused by Leishmania braziliensis, using 15% paromomycin-Aquaphilic, was superior to a negative vehicle control and comparable in efficacy to a positive control, according to a randomized control study (ClinicalTrials.gov identifier: NCT03096457) published in Clinical Infectious Diseases.
In this study, cure rates after 6 months of follow-up were reported for 40 patients treated with 15% paromomycin in Aquaphilic vs 20 patients treated with Aquaphilic vehicle vs 20 patients treated with the positive control, intralesional pentamidine. Cure rates for paromomycin were 77.5% (95% CI, 62.5%-88%), 10% (95% CI, 3%-30%) for Aquaphilic vehicle (P < .0001 vs paromomycin-Aquaphilic), and 70% (95% CI, 48%-85.5%) for the positive control. Grade 1 adverse reactions occurred in only 5% to 10% of patients treated with paromomycin-Aquaphilic and the Aquaphilic vehicle.
The wider application of these results remains in question because of the modest study size and the fact that treatment for only a single species causing New World cutaneous leishmaniasis was tested. However, according to investigators, “this formulation appears superior to placebo against a mild, prevalent cause of Old World [cutaneous leishmaniasis] and against an aggressive, prevalent cause of New World [cutaneous leishmaniasis],” and the treatment is well tolerated. The primary disadvantage compared with the current local intervention of intralesional injections is the requirement of daily administration for 20 days.
The investigators welcomed further evaluation of 15% paromomycin-Aquaphilic, and concluded that these results enlarge the potential use of this treatment for cutaneous leishmaniasis in general.
Soto J, Soto P, Ajata A, et al. Topical 15% paromomycin-Aquaphilic for Bolivian Leishmania braziliensis cutaneous leishmaniasis: A randomized, placebo-controlled trial [published online September 27 2018]. Clin Infect Dis. doi: 10.1093/cid/ciy619