A Randomized Trial to Compare Topical MJ1 with Routine Care for the Treatment of Cutaneous Leishmaniasis

• Main Authors: Mohsen Janghorbani (Author), Masoumeh Faraji (Author), Javad Ramazanpour (Author), Reza Fadaei (Author)
• Format: Book
• Published: Iranian Journal of Health, Safety and Environment, 2015-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2345-3206; 2345-5535
• Keywords: Cutaneous Leishmaniasis, Meglumine Antimonate, MJ1 Agent, Iran; Public aspects of medicine; RA1-1270
• Source: Iranian Journal of Health, Safety and Environment, Vol 2, Iss 3, Pp 296-303 (2015)

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 0.5-1 cc 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<0.001). No sever adverse effect occurred. The findings highlight that topical treatment with MJ1 agent was much more effective than routine care and is safe and well tolerated.