Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis.

Summary

Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 15 different species of the protozoan parasite Leishmania. The CL usually begins with a papule at the site of the sandfly bite, increasing in size to form a nodule that ulcerates in a period of 1 to 3 months. The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately 102 countries worldwide suffer from different forms of CL. Among the different parasites that cause CL, L.tropica in the Old World and L.braziliensis in the New World are considered to be the most important due to the difficulty of healing, the public importance and the severity of the disease. Pentavalent antimony remains the first choice drug for the treatment of CL and the evidence to support its use is sometimes based on qualitative, retrospective and uncontrolled observations, with only some controlled clinical studies. Antimonials are widely used despite their toxicity, difficulty in the route of administration, and high cost. Miltefosine (hexadecylphosphocholine), an oral medication that has proven effective for some types of Leishmania, is potentially teratogenic, is contraindicated during pregnancy and requires appropriate counseling for female patients of childbearing age.

Timeline

Start

2021-01

Primary completion

2021-02

Completion

2022-07

Outcome

Outcome not reported

Stopped: “Tthe study is in the approval phase by local regulatory authorities”

Publications

• 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 Blum J, Desjeux P, Schwartz E, Beck B, Hatz C. Treatment of cutaneous leishmaniasis among travellers. J Antimicrob Chemother. 2004 Feb;53(2):158-66. doi: 10.1093/jac/dkh058. Epub 2004 Jan 16.
• Background Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, Berman JD. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg. 2008 Feb;78(2):210-1.
• Background WHO technical report series; no. 949. Control of the leishmaniasis: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010.
• Background Silva NS, Muniz VD. [Epidemiology of American tegumentary leishmaniasis in the State of Acre, Brazilian Amazon]. Cad Saude Publica. 2009 Jun;25(6):1325-36. doi: 10.1590/s0102-311x2009000600015. Portuguese.
• Background Almeida OL, Santos JB. Advances in the treatment of cutaneous leishmaniasis in the new world in the last ten years: a systematic literature review. An Bras Dermatol. 2011 May-Jun;86(3):497-506. doi: 10.1590/s0365-05962011000300012. English, Portuguese.
• Background Tiuman TS, Santos AO, Ueda-Nakamura T, Filho BP, Nakamura CV. Recent advances in leishmaniasis treatment. Int J Infect Dis. 2011 Aug;15(8):e525-32. doi: 10.1016/j.ijid.2011.03.021. Epub 2011 May 24.
• Background Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
• Background Velez I, Lopez L, Sanchez X, Mestra L, Rojas C, Rodriguez E. Efficacy of miltefosine for the treatment of American cutaneous leishmaniasis. Am J Trop Med Hyg. 2010 Aug;83(2):351-6. doi: 10.4269/ajtmh.2010.10-0060.
• Background Croft SL, Seifert K, Yardley V. Current scenario of drug development for leishmaniasis. Indian J Med Res. 2006 Mar;123(3):399-410.
• Background Pearson, R. D., and A. de Querez Sousa. 1995 Leishmania species: visceral (kala-azar), cutaneous, and mucosal leishmaniaisis. p. 2428-2442. In G. L. Mandell, J. E. Bennett, and R. Dolin (ed.) Principles and practice of infectious diseases. Churchill Livingstone, New York, N.Y.
• Background Votypka J, Kasap OE, Volf P, Kodym P, Alten B. Risk factors for cutaneous leishmaniasis in Cukurova region, Turkey. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):186-90. doi: 10.1016/j.trstmh.2011.12.004. Epub 2012 Jan 26.
• Background Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
• Background Reveiz L, Maia-Elkhoury AN, Nicholls RS, Romero GA, Yadon ZE. Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update. PLoS One. 2013 Apr 29;8(4):e61843. doi: 10.1371/journal.pone.0061843. Print 2013.
• Background Lee SA, Hasbun R. Therapy of cutaneous leishmaniasis. Int J Infect Dis. 2003 Jun;7(2):86-93. doi: 10.1016/s1201-9712(03)90002-6.
• Background Lopez L, Robayo M, Vargas M, Velez ID. Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Trials. 2012 May 17;13:58. doi: 10.1186/1745-6215-13-58.
• Background Organizacion Panamerica de la Salud, OPS. Leishmaniasis en las Americas: Recomendaciones para el tratamiento. 2013. http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=22226&Itemid
• Background Velasco-Castrejon O, Walton BC, Rivas-Sanchez B, Garcia MF, Lazaro GJ, Hobart O, Roldan S, Floriani-Verdugo J, Munguia-Saldana A, Berzaluce R. Treatment of cutaneous leishmaniasis with localized current field (radio frequency) in Tabasco, Mexico. Am J Trop Med Hyg. 1997 Sep;57(3):309-12. doi: 10.4269/ajtmh.1997.57.309.

Drugs

Indications