In this study we demonstrated the potential association effect of conventional amphotericin B (Amph B) and Gallic acid (GA) or Ellagic acid (EA) in topical formulation for treatment of cutaneous leishmaniasis in BALB/c mice. Preliminary stability tests and in vitro drug release studies with Amph B, GA, Amph B + GA, EA and Amph B + EA in the composition and in vivo treatment of BALB/c mice infected by Leishmania major were performed. After 40 days of infection, the animals were divided into 6 groups, treated 2x/day, for 21 days with the gel of Amph B, GA, Amph B + GA, EA and Amph B + EA and the negative control group was treated with the vehicle. In the animals that received treatment there was reduction of the lesion size and reduction of the parasitic load. In the histopathological analysis of the treatments with GA, EA and associated Amph B, circumscribed lesion with presence of fibroblasts, granulation tissue and collagens deposition, as well as presence of activated macrophages. The formulations containing GA and EA activated macrophages in all evaluated parameters, resulting, therefore, in the activation of cells of the innate immune response, which can generate healing and protection. GA and EA produced an association effect with Amph B, which makes them promising their use with conventional Amph B in the treatment of cutaneous leishmaniasis.
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