First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.

<h4>Background</h4>Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective t...

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Autores principales: Cesar Miranda-Verastegui, Gianfranco Tulliano, Theresa W Gyorkos, Wessmark Calderon, Elham Rahme, Brian Ward, Maria Cruz, Alejandro Llanos-Cuentas, Greg Matlashewski
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spelling oai:doaj.org-article:506f33e49e7548ba8ca415edae800b2e2021-11-25T06:33:15ZFirst-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.1935-27271935-273510.1371/journal.pntd.0000491https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e2009-07-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19636365/?tool=EBIhttps://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated.<h4>Methods</h4>A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period.<h4>Results</h4>Of the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm.<h4>Conclusion</h4>The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant.<h4>Trial registration</h4>Clinical Trials.gov NCT00257530.Cesar Miranda-VerasteguiGianfranco TullianoTheresa W GyorkosWessmark CalderonElham RahmeBrian WardMaria CruzAlejandro Llanos-CuentasGreg MatlashewskiPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 3, Iss 7, p e491 (2009)
institution DOAJ
collection DOAJ
language EN
topic Arctic medicine. Tropical medicine
RC955-962
Public aspects of medicine
RA1-1270
spellingShingle Arctic medicine. Tropical medicine
RC955-962
Public aspects of medicine
RA1-1270
Cesar Miranda-Verastegui
Gianfranco Tulliano
Theresa W Gyorkos
Wessmark Calderon
Elham Rahme
Brian Ward
Maria Cruz
Alejandro Llanos-Cuentas
Greg Matlashewski
First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
description <h4>Background</h4>Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated.<h4>Methods</h4>A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period.<h4>Results</h4>Of the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm.<h4>Conclusion</h4>The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant.<h4>Trial registration</h4>Clinical Trials.gov NCT00257530.
format article
author Cesar Miranda-Verastegui
Gianfranco Tulliano
Theresa W Gyorkos
Wessmark Calderon
Elham Rahme
Brian Ward
Maria Cruz
Alejandro Llanos-Cuentas
Greg Matlashewski
author_facet Cesar Miranda-Verastegui
Gianfranco Tulliano
Theresa W Gyorkos
Wessmark Calderon
Elham Rahme
Brian Ward
Maria Cruz
Alejandro Llanos-Cuentas
Greg Matlashewski
author_sort Cesar Miranda-Verastegui
title First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
title_short First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
title_full First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
title_fullStr First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
title_full_unstemmed First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
title_sort first-line therapy for human cutaneous leishmaniasis in peru using the tlr7 agonist imiquimod in combination with pentavalent antimony.
publisher Public Library of Science (PLoS)
publishDate 2009
url https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e
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