Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis

Summary

The goal of this clinical trial is to learn if the drug MILTEFOSINE, used topically in a hydrogel, works to treat non-complicated cutaneous leishmaniasis (CL) in adults. It will also learn about the safety of the drug MILTEFOSINE used topically. The main questions it aims to answer are: * Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development? * What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%. Participants will: * Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days. * Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests. * Take a photo once a week for checkups, and keep a note of their symptoms

Timeline

Start

2026-01-01

Primary completion

2026-07-20

Completion

2026-08-30

Publications

• Background Castro MD, Gomez MA, Kip AE, Cossio A, Ortiz E, Navas A, Dorlo TP, Saravia NG. Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02198-16. doi: 10.1128/AAC.02198-16. Print 2017 Mar.
• Background Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012 Sep;4(3):153-63. doi: 10.1016/j.inhe.2012.06.004.
• Background Aronson N, Herwaldt BL, Libman M, Pearson R, Lopez-Velez R, Weina P, Carvalho E, Ephros M, Jeronimo S, Magill A. Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Am J Trop Med Hyg. 2017 Jan 11;96(1):24-45. doi: 10.4269/ajtmh.16-84256. Epub 2016 Dec 7. No abstract available.
• Background Andrade HM, Toledo VP, Pinheiro MB, Guimaraes TM, Oliveira NC, Castro JA, Silva RN, Amorim AC, Brandao RM, Yoko M, Silva AS, Dumont K, Ribeiro ML Jr, Bartchewsky W, Monte SJ. Evaluation of miltefosine for the treatment of dogs naturally infected with L. infantum (=L. chagasi) in Brazil. Vet Parasitol. 2011 Sep 27;181(2-4):83-90. doi: 10.1016/j.vetpar.2011.05.009. Epub 2011 May 14.
• Results Neira LF, Mantilla JC, Escobar P. Monitoring cutaneous leishmaniasis lesions in mice undergoing topical miltefosine treatment. Sci Pharm. 2023; 91(4):54. https://doi.org/10.3390/scipharm91040054
• Results Neira LFb., Peña DP., Vera AM., Mantilla JC., Escobar P. Leishmaniasis cutánea inducida por especies de Leishmania Viannia en ratones BALB/c y eficacia de un tratamiento tópico. Rev Univ Ind Santander. Salud. 2019 Mar;51(1):33-42.doi.org/10.18273/ revsal.v51n1-2019004
• Results Neira LF, Mantilla JC, Escobar P. Anti-leishmanial activity of a topical miltefosine gel in experimental models of New World cutaneous leishmaniasis. J Antimicrob Chemother. 2019 Jun 1;74(6):1634-1641. doi: 10.1093/jac/dkz049.
• Results Escobar P, Yardley V, Croft SL. Activities of hexadecylphosphocholine (miltefosine), AmBisome, and sodium stibogluconate (Pentostam) against Leishmania donovani in immunodeficient scid mice. Antimicrob Agents Chemother. 2001 Jun;45(6):1872-5. doi: 10.1128/AAC.45.6.1872-1875.2001.

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Indications