BACKGROUND: Cutaneous leishmaniasis (CL) is a vector-borne parasitic disease caused by a range of Leishmania species. Many treatment modalities have been proposed, although pentavalent antimonials are still considered to be the first-line treatment of CL. However, due to the high cost and adverse effects of antimonials, as well as an increase in the number of resistant strains of CL to antimonials, this study was conducted to compare the efficacy of oral ketoconazole with intralesional meglumine antimoniate (Glucantime, Specia, Paris, France) for the treatment of CL. METHODS: A total of 96 patients with CL were enrolled in the study. The diagnosis of CL was confirmed parasitologically using direct skin smears or skin biopsies. The patients were randomly allocated to two treatment groups. Group A (64 patients) was treated with ketoconazole 600 mg/day for adults and 10 mg/kg per day for children for 30 days. Group B (32 patients) was treated with 6-8 biweekly intra-lesional injections of meglumine antimoniate (Glucantime). Both groups were followed for 6 months after termination of treatment. RESULTS: The results showed complete clinical cure in 89% of cases in Group A (treated with oral ketoconazole) and 72% of cases in Group B (treated with intra-lesional Glucantime). This difference was statistically significant (p < 0.05). No significant side effects were observed in either treatment group. CONCLUSION: Oral ketoconazole can be an effective treatment modality in CL, especially in children afflicted with this disease.