The rationale for development of a topical formulation of amphotericin B was to provide a treatment to be applied locally at the CL lesion, showing high anti-parasitic effect, but without the systemic toxicity associated with amphotericin B. A Phase Ib/II open-label, randomized, non-comparative, two-arm exploratory study is being conducted in Colombia. Initially planned to include only patients with CL caused by L. braziliensis, recruitment was widened to include patients with CL caused by L. panamensis. Enrolment of all 80 patients was completed in November 2015, and preliminary data on cure will be available in 2016.

If Anfoleish is shown to be efficacious against L. braziliensis and L. panamesis, a multi-country Phase III study will be planned in Latin America.