摘要:The objective of this study was to assess the relative efficacy and tolerability of topical MJ1 compared to routine care in the treatment of histologically proven CL. A total of 150 patients with 297 lesions were randomly allocated to receive either topical MJ1 agent as a paste to applied to the lesions without cover three times a day for 20 days or routine care (intramuscular injection of meglumine antimonate 20 mg/kg/day for 2 weeks or intralesional 0.5-1CC for a total of four injection with one week interval). The primary end point of this study was the clinical cure of the lesion. Response to treatment was assessed at 1, 2, 3 and 8 weeks after start of therapy. Of the 132 lesions treated with MJ1, the mean size of lesions decreased from 423.9 to 30.4 mm2, 111 (84.1%) were reduced in size and 21 (15.9%) not responded. Correspondingly, in the 165 lesions treated with routine care, the mean size of lesions slightly increased from 295.8 to 330.5 mm2, 82 (49.7%) were reduced in size and 83 (50.3%) not responded. The differences were statistically significant (P