First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony.
Background 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 anti...
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ftdoajarticles:oai:doaj.org/article:506f33e49e7548ba8ca415edae800b2e 2023-05-15T15:11:50+02:00 First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. Cesar Miranda-Verastegui Gianfranco Tulliano Theresa W Gyorkos Wessmark Calderon Elham Rahme Brian Ward Maria Cruz Alejandro Llanos-Cuentas Greg Matlashewski 2009-07-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0000491 https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e EN eng Public Library of Science (PLoS) https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19636365/?tool=EBI https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000491 https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e PLoS Neglected Tropical Diseases, Vol 3, Iss 7, p e491 (2009) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2009 ftdoajarticles https://doi.org/10.1371/journal.pntd.0000491 2022-12-31T04:58:49Z Background 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. Methods 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. Results 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. Conclusion The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant. Trial registration Clinical Trials.gov NCT00257530. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 3 7 e491 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
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. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background 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. Methods 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. Results 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. Conclusion The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant. Trial registration Clinical Trials.gov NCT00257530. |
format |
Article in Journal/Newspaper |
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://doi.org/10.1371/journal.pntd.0000491 https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 3, Iss 7, p e491 (2009) |
op_relation |
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19636365/?tool=EBI https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000491 https://doaj.org/article/506f33e49e7548ba8ca415edae800b2e |
op_doi |
https://doi.org/10.1371/journal.pntd.0000491 |
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PLoS Neglected Tropical Diseases |
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3 |
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7 |
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e491 |
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