Treatment of Cutaneous Leishmaniasis With Oral Itraconazole

Abstract

We conducted an open pilot study with the following inclusion criteria: (1) parasites detected on direct smear or in anatomopathological preparations, or strongly suggestive histology together with positive serology; (2) absence or failure of previous other specific antileishmanial treatnnent; (3) absence of spontaneous healing tendency; and (4) informed consent obtained. Pregnancy was an exclusion criterion.Direct smears were taken from the edge of lesions, fixed with methanol and stained with Giemsa stain. Skin biopsies (edge of lesions) were defined as positive when amastigotes were identified. If amastigotes could not be Identified, leishmaniasis was considered the most likely diagnosis when focal accumulations of histiocytes were observed in a dense dermal mononuclear infiltrate, associated with hyperplastic epidermis or necrosis and ulceration. Serological screening was performed with a precipitation-in-gel assay. Positive and suspect sera were analyzed with a direct agglutination test (DAT) as described previously^ and with immunoelectrophoresis.Î traconazole, 100 mg per capsule, was used. Adults were given 200 mg of itraconazole per os per day. Children received 5 mg/kg/day (maximum 200 mg/day). Treatment lasted for 4 or 8 weeks (depending upon the degree of healing after 4 weeks). Patients were seen at 0, 4, and 8 weeks. Blood for full blood count, urinalysis, and biochemistry tests (urea, creatinine, uric acid, liver enzymes, lactic dehydrogenase) was taken during every visit to detect toxicity. Final assessment was confirmed whenever possible at 6 months. RESULTSWe identified 22 patients (age 2-64 years; 16 men, 6 women) witb CL by the presence of amastigotes (n -20) or strongly suggestive histology with positive serology

A randomized, double‐blind, placebo‐controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis

“…(73%), 9 Dogra (75%) 8 and Van Den Enden et al . (78%) 16 even though the dose of itraconazole and the duration of treatment, as well as the method of evaluation in these studies seem to be similar to ours. However, these studies were conducted on a smaller study population.…”

“…Oral itraconazole has been reported as a possibly promising antileishmanial agent 15 . It showed activity against Leishmania not only in vitro 4 but also in some clinical studies, 8,9,16 . However, in this study itraconazole did not seem to be statistically more efficacious than placebo.…”

Therapeutic options for cutaneous leishmaniasis

“…Cure rates between 55% and 78% were documented by using itraconazole 200 mg/day for 4-8 weeks (44,45). In a placebo-controlled study complete healing was observed in 59% of patients receiving itraconazole (7 mg/kg day given for 3 weeks to 30 days) and 44% in the placebo group (46).…”

Recent Trends in the Treatment of Cutaneous Leishmaniasis

“…35 Itraconazole (200 mg/day for 4-8 weeks) cured 15 (79%) of 19 patients from India who had CL, and was reported to be more easily tolerated than ketoconazole. 36 Metronidazole (another imidazole derivative) is mainly used for amebiasis, trichomoniasis and anaerobic infections. There are conflicting reports regarding its activity in leishmaniasis.…”