Comparison of efficacy of intralesional injection of meglumine anti-moniate once-weekly with twice-weekly in the treatment of anthroponotic cutaneous leishmaniasis in Mashhad: a randomized clinical trial

Cutaneous leishmaniasis (CL) is endemic in Iran, where it is one of the most important health problems. Both anthroponotic CL (ACL) caused by L. tropica and zoonotic CL (ZCL) caused by L. major are reported. Antimoniate derivatives as the standard therapy for CL need multiple injections and are not easy to tolerate for the patients. This study was conducted in Mashhad to compare the efficacy of weekly versus twice a week intralesional injections of meglumine antimoniate (MA) in the treatment of ACL. This randomised controlled trial was performed during 2006 to 2008 in Mashhad, Iran. Using computerized sequence of random numbers, participants were randomly allocated in the two arms of the study: one receiving weekly and the other receiving twice-a-week intralesional injections of MA. The lesion size, induration and healing rate were assessed, recorded and compared. Healing was defined as complete re-epithelialisation and disappearance of induration. A total of 252 suspected CL patients with 372 lesions were screened. 82 parasitologically proven cases with 121 lesions caused by L. tropica were included and 74 patients with 113 lesions completed the study. At 12th week after initiation of treatment, complete healing was observed in 38 out of 44 lesions (86.4%) in the group which received weekly intralesional MA injection. The median time-to-heal in this group was 36 days (95% confidence interval [CI]: 32.0-39.9). Complete healing was recorded in 60 out of 69 lesions (86.9%) in the group which received twice a week intralesional injections of MA with a median time-to-heal of 25 days (95% CI: 20.9-29.1). While no significant difference was observed between the two groups in terms of complete healing rate (P=0.999), time-to-heal was significantly different between the 2 groups (P=0.003). It seems that the effectiveness of twice-weekly intralesional injections of MA is similar to once-weekly regimen while the former regimen causes more rapid healing of lesions.