Terbinafine in the treatment of cutaneous leishmaniasis: a pilot study.

Twenty-seven patients were randomly picked for an open pilot study using terbinafine with a dose range of 250-500 mg/day for 4 weeks. The inclusion criteria were as follows: (1) the patient had to be aged 5 years or older; (2) the patient could be of either sex; (3) any number or location of the lesions was allowed; (4) parasitologic confirmation was required; (5) the patient was allowed no previous treatment; (6) pregnant or lactating patients were excluded; (7) informed consent from the patient or his/her parents was required. The parasitologic diagnosis was carried out by a slit smear technique followed by a Giemsa stain for parasite identification. Terbinafine was given in two different doses to two groups sorted according to age. The groups were as follows: Group 1, 5-15 years, 125 mg orally twice daily for 4 weeks: Group 2, > 15 years, 250 mg orally twice daily for 4 weeks. Laboratory blood investigations including complete blood count, creatinine, urea, and liver function tests were carried out initially and at 2 weeks and 4 weeks. Clinical response was evaluated by assessing the per cent of improvement of erythema, induration, and ulceration at 2 weeks and at 4 weeks after admission. The final assessment was reported at 4 weeks: complete cure, 100% improvement with no relapse; partial cure, > or = 60% improvement; failure, < 60% improvement. Overall clinical response included patients with both complete and partial cure. Follow-up for patients with complete cure was carried out monthly for 6 months to assess the relapse rate. Patients with partial cure or failure were switched to sodium stibogluconate intralesionally.

RCT Entities:   Population Interventions Outcomes