Proposal of a topical alternative for Cutaneous Leishmaniasis

Abstract

Leishmaniasis is a group of diseases caused by a flagellated protozoan belonging to different species of the genus Leishmania, causing infections of the skin (cutaneous Leishmaniasis), mucous membranes (mucocutaneous Leishmaniasis) and internal organs (visceral Leishmaniasis)1 . This disease is present in 88 countries worldwide, mainly in South and Central America, Africa, Asia and Southern Europe 2. In Honduras, this infection is endemic3, and by 2022, 1,565 new cases of cutaneous Leishmaniasis were reported4 . The treatment of choice for all forms of this disease has been meglumine antimoniate, known commercially as Glucantime® (AMG), which is distributed for intravenous (IV) administration and produces adverse effects such as fever, nausea, vomiting, abdominal pain and nephrotoxicity. In some cases, it may be necessary to adjust the dosage of the drug or discontinue treatment if side effects are severe5 . Another therapeutic option for the treatment of cutaneous Leishmaniasis is Amphotericin B deoxycholate (AMB), which, like AMG, is administered by IV but produces immediate adverse effects such as fever, chills, nausea, vomiting, headache, anaphylactic shock, arrhythmias and liver failure6 . Although lipid formulations of AMB have been developed to reduce the toxic effects of the molecule and improve its effectiveness (liposomal, lipid complex, colloidal suspension), these presentations are expensive and make it impossible for patients to purchase this treatment. Likewise, there are less risky alternatives such as intralesional application with AMG and thermotherapy7 . However, despite the efforts to research and develop new treatments, no topical treatment for cutaneous Leishmaniasis has been marketed. Topical treatments offer several advantages, including localized action, reduced systemic side effects, convenience of use and rapid absorption, making them a practical option for treating various medical and dermatological conditions. In this regard, we propose the development of a potential product that can be easily and rapidly prepared in a magistral formulation as a therapeutic alternative to Cutaneous Leishmaniasis.