Comparison of Intralesional Meglumine Antimonite along with oral Itraconazole to Intralesional Meglumine Antimonite in the treatment of Cutaneous Leishmaniasis

Background & Objective: Cutaneous leishmaniasis (CL) is endemic in developing countries like Pakistan. Pentavalent antimonials are still drug of choice, despite being toxic and intolerable for patients. Second line treatments have been extensively studied but the results of their efficacy are conflicting. This, to our knowledge, will be the first study in this regard. Our objective was to determine if combination of oral itraconazole with intralesional (IL) meglumine antimoniate (MA) reduces the duration of treatment for cutaneous leishmaniasis, as compared to intralesional MA alone. Methods: A randomized controlled trial (single blinded) was carried out from August 2017 till December 2017 on 69 patients who fulfilled inclusion criteria. They were assigned to Group-A or B by lottery method. Group-A patients received IL MA once a week while Group-B received oral itraconazole 200mg, once daily, for six weeks along with similar regimen of IL MA as Group-A. The patients were assessed every three weeks by the blinded assessor till clinical cure was achieved. A follow up visit, two months after clinical cure was done to look for relapse of the disease. Results: Thirty patients in Group-A and 35 patients in Group-B completed the study. At 3, 6, 9 and 12 weeks the patients were assessed for: no, partial or complete response and results of the two groups were compared for statistical significance. The p-values of 0.20, 0.57 and 0.11 at 3, 6 and 9 weeks, respectively, depict that there was no significant difference at any step of assessment between the two groups in terms of healing. The p values of each t test was>0.05 refuting the hypothesis. Conclusion: Combination of oral itraconazole with intralesional MA offered no benefit over intralesional MA alone in the management of cutaneous leishmaniasis in terms of duration of therapy.