A randomized, double-blind, clinical trial of topical clotrimazole versus miconazole for treatment of cutaneous leishmaniasis in the eastern province of Saudi Arabia.

The parenteral treatment currently available for cutaneous leishmaniasis (CL) is painful and potentially exposes patients to serious side effects. Thus, effective, topical therapy would be valuable. We assessed the efficacy of topical 1% clotrimazole and 2% miconazole creams in relation to early healing of lesions in CL in a randomized, double-blind clinical trial in 54 patients with 151 lesions treated for 30 consecutive days. Response to treatment was assessed at two weeks and 30 days and classified as fully healed, size reduced, no change, and size increased or worse. Of 89 lesions treated with clotrimazole, 14 (15.7%) healed fully, 42 (47.2%) were reduced in size, 20 (22.5%) showed no change, and 13 (14.6%) got worse. Correspondingly, in the 62 lesions treated with miconazole, none healed fully, 22 (35.5%) were reduced in size, 16 (25.8%) showed no change, and 24 (38.7%) got worse. The differences were statistically significant (P < 0.001). No side effects were observed. It is concluded that clotrimazole was the more effective of the two imidazoline compounds and is recommended as initial treatment for simple lesions.