Effect of Adjunctive Topical Liposomal Azithromycin on Systemic Azithromycin on Old World Cutaneous Leishmaniasis: A Pilot Clinical Study

Abstract

The treatment of Cutaneous Leishmaniasis (CL) is complex, and the search for safer, more efficient, and cost-effective treatments is ongoing. This study aimed to evaluate the efficacy of the combination of liposomal and oral azithromycin as the first clinical study against CL. This assessor-blind, randomized clinical trial was conducted in out-patients Leishmaniasis clinic of Skin Diseases and Leishmaniasis. The cutaneous lesions of eligible participants were randomized to receive either oral azithromycin or the combined oral and topical liposomal azithromycin. All participants received 250 mg of azithromycin twice daily or 8 mg/per kg for 4 weeks. In the combination group, a topical liposomal formulation of 0.04 mmol/mL of azithromycin was administered as 0.2-0.5 cc twice daily according to the lesion size in order to make a thin layer of the drug on the surface of the lesion. The size and induration changes from baseline to the end of the study were analyzed. Twenty-one lesions of 13 patients in the combination group and 20 lesions of 14 patients in the oral group were recruited. The mean +/- SD of improvement was significantly different between two groups after 12 weeks (3.89 +/- 0.46 vs. 3.15 +/- 1.23 P = 0.02 combination group vs. oral group respectively). The patients did not experience any systemic adverse effects related to azithromycin and the only adverse effects related to topical treatment were mild pruritus in 2 cases. In conclusion, the combination of oral and topical liposomal formulation of azithromycin is safe and effective to treat CL.