Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala.

Abstract

Abstract. A double-blind, randomized trial was undertaken in Guatemala to determine the therapeutic efficacy of an ointment for the treatment of cutaneous leishmaniasis that contained 15% paromomycin and 12% methylbenzethonium chloride and that was applied twice a day for 20 days. The treatment group included 35 patients, and the placebo group included 33 patients. The initial clinical response rate (13 weeks after completing the treatment) was 91.4% in the treatment group and 39.4% in the placebo group. The final clinical response rate at the 12-month followup examination was 85.7% (31 of 35) in the treatment group and 39.4% (13 of 33) in the placebo group (P Յ 0.001). In general, the treatment was well tolerated and was never interrupted because of adverse effects. The number of adverse effects reported in the placebo group was lower than in the treatment group (16 events versus 30 events). All adverse effects reported by patients disappeared within 1 week of completing the treatment. Our findings show that the combination of paromomycin with methylbenzethonium chloride for 20 days is a good alternative for antimonial treatments of cutaneous leishmaniasis in Guatemala.

Polymerase Chain Reaction Detection of Leishmania kDNA from the Urine of Peruvian Patients with Cutaneous and Mucocutaneous Leishmaniasis

“…Although the overall sensitivity of urine PCR for the diagnosis of CL was sub-optimal compared with the very sensitive molecular assays on invasively obtained scrapings and biopsies of cutaneous and mucosal lesions, [1][2][3][4][5] the presence of detectable kDNA in the urine may suggest a potential role in categorizing patients as candidates for different therapies, especially given the over-representation of mucosal disease in the group with detectable kDNA in the urine. Given the toxicity associated with currently used parenteral therapies for CL (such as pentavalent antimonials and amphotericin B), 1 , 25 there is a movement toward use of topical therapies such as paromomycin, [26][27][28][29][30] cryo-or thermotherapy, [31][32][33] or intralesional antimonials. [32][33][34] However, patients with detectable kDNA in urine may represent a group of patients with less localized forms of disease that may be most amenable to systemic therapy.…”

Leishmaniasis in travelers: A literature review

“…The above-mentioned advantages of topical therapy are easily obtained by formulations containing 15% paromomycin, an aminoglycoside antibiotic, with methlybenzethonium in white soft paraffin or urea and white soft paraffin, or with 0.5% gentamicin. The combination of paromomycin with methylbenzethonium appears to be more effective than the combination with urea, but it causes the strongest local inflammatory reactions [132,163]…”

Study of In Vitro Drug Release and Percutaneous Absorption of Fluconazole from Topical Dosage Forms

“…In animals experimentally infected by Leishmania amazonensis or L.major, the activity of formulations containing only PA is usually low (16,17). Another ointment containing PA and methylbenzethonium chloride has proven efficacy, but it was found to be toxic and irritating (18,19). Also it is important to mention that Leishmania brazilensis and Leishmania panamensis have been demonstrated to be less sensitive to PA (13).…”