Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers
In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation. Travelers with 1-10 lesions of confirmed C...
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| Veröffentlicht in: | PLoS neglected tropical diseases 2023-08, Vol.17 (8), p.e0011492-e0011492 |
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| creator | Mouri, Oussama Melenotte, Cléa Guéry, Romain Cotteret, Camille Schweitzer-Chaput, Arnaud Perignon, Alice Thellier, Marc Bourrat, Emmanuelle Kaguelidou, Florentia Siriez, Jean Yves Malvy, Denis Gangneux, Jean-Pierre Duvignaud, Alexandre Ravel, Christophe Cisternino, Salvatore Ransom, Janet Caumes, Eric Lortholary, Olivier Grogl, Max Buffet, Pierre |
| description | In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation.
Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months.
Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group.
In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials. |
| doi_str_mv | 10.1371/journal.pntd.0011492 |
| format | Article |
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Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months.
Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group.
In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0011492</identifier><identifier>PMID: 37561802</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Aminoglycoside antibiotics ; Aminoglycosides ; Biology and Life Sciences ; Blood tests ; Care and treatment ; Clinical trials ; Complications and side effects ; Cutaneous leishmaniasis ; Dermatology ; Diagnosis ; FDA approval ; Gentamicin ; Health aspects ; Human health and pathology ; Infectious diseases ; Informed consent ; Leishmaniasis, Cutaneous ; Lesions ; Life Sciences ; Medicine and Health Sciences ; Parasites ; Parasitic diseases ; Paromomycin ; Patient outcomes ; Patients ; Pentamidine isethionate ; People and places ; Pharmaceutical sciences ; Pharmacology ; Polymerase chain reaction ; Protocols ; Protozoa ; Pruritus ; Research and Analysis Methods ; Santé publique et épidémiologie ; Surveillance ; Toxicity ; Travelers ; Tropical diseases ; Ulcers ; Vector-borne diseases</subject><ispartof>PLoS neglected tropical diseases, 2023-08, Vol.17 (8), p.e0011492-e0011492</ispartof><rights>Copyright: © 2023 Mouri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2023 Public Library of Science</rights><rights>2023 Mouri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Attribution</rights><rights>2023 Mouri et al 2023 Mouri et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c608t-94808a7f681ccef391304ca22628da671bacb4376e14b8967b270f2d9ed02a023</cites><orcidid>0000-0003-3159-1061 ; 0000-0002-7842-5602 ; 0000-0001-8500-3574 ; 0000-0003-4867-2423 ; 0000-0002-7590-582X ; 0000-0002-8325-8060</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443860/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10443860/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79343,79344</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37561802$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04197812$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Mouri, Oussama</creatorcontrib><creatorcontrib>Melenotte, Cléa</creatorcontrib><creatorcontrib>Guéry, Romain</creatorcontrib><creatorcontrib>Cotteret, Camille</creatorcontrib><creatorcontrib>Schweitzer-Chaput, Arnaud</creatorcontrib><creatorcontrib>Perignon, Alice</creatorcontrib><creatorcontrib>Thellier, Marc</creatorcontrib><creatorcontrib>Bourrat, Emmanuelle</creatorcontrib><creatorcontrib>Kaguelidou, Florentia</creatorcontrib><creatorcontrib>Siriez, Jean Yves</creatorcontrib><creatorcontrib>Malvy, Denis</creatorcontrib><creatorcontrib>Gangneux, Jean-Pierre</creatorcontrib><creatorcontrib>Duvignaud, Alexandre</creatorcontrib><creatorcontrib>Ravel, Christophe</creatorcontrib><creatorcontrib>Cisternino, Salvatore</creatorcontrib><creatorcontrib>Ransom, Janet</creatorcontrib><creatorcontrib>Caumes, Eric</creatorcontrib><creatorcontrib>Lortholary, Olivier</creatorcontrib><creatorcontrib>Grogl, Max</creatorcontrib><creatorcontrib>Buffet, Pierre</creatorcontrib><title>Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation.
Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months.
Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group.
In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials.</description><subject>Aminoglycoside antibiotics</subject><subject>Aminoglycosides</subject><subject>Biology and Life Sciences</subject><subject>Blood tests</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Cutaneous leishmaniasis</subject><subject>Dermatology</subject><subject>Diagnosis</subject><subject>FDA approval</subject><subject>Gentamicin</subject><subject>Health aspects</subject><subject>Human health and pathology</subject><subject>Infectious diseases</subject><subject>Informed consent</subject><subject>Leishmaniasis, Cutaneous</subject><subject>Lesions</subject><subject>Life Sciences</subject><subject>Medicine and Health 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Journals</collection><jtitle>PLoS neglected tropical diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mouri, Oussama</au><au>Melenotte, Cléa</au><au>Guéry, Romain</au><au>Cotteret, Camille</au><au>Schweitzer-Chaput, Arnaud</au><au>Perignon, Alice</au><au>Thellier, Marc</au><au>Bourrat, Emmanuelle</au><au>Kaguelidou, Florentia</au><au>Siriez, Jean Yves</au><au>Malvy, Denis</au><au>Gangneux, Jean-Pierre</au><au>Duvignaud, Alexandre</au><au>Ravel, Christophe</au><au>Cisternino, Salvatore</au><au>Ransom, Janet</au><au>Caumes, Eric</au><au>Lortholary, Olivier</au><au>Grogl, Max</au><au>Buffet, Pierre</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers</atitle><jtitle>PLoS neglected tropical diseases</jtitle><addtitle>PLoS Negl Trop Dis</addtitle><date>2023-08-10</date><risdate>2023</risdate><volume>17</volume><issue>8</issue><spage>e0011492</spage><epage>e0011492</epage><pages>e0011492-e0011492</pages><issn>1935-2735</issn><issn>1935-2727</issn><eissn>1935-2735</eissn><abstract>In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation.
Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months.
Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group.
In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>37561802</pmid><doi>10.1371/journal.pntd.0011492</doi><orcidid>https://orcid.org/0000-0003-3159-1061</orcidid><orcidid>https://orcid.org/0000-0002-7842-5602</orcidid><orcidid>https://orcid.org/0000-0001-8500-3574</orcidid><orcidid>https://orcid.org/0000-0003-4867-2423</orcidid><orcidid>https://orcid.org/0000-0002-7590-582X</orcidid><orcidid>https://orcid.org/0000-0002-8325-8060</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1935-2735 |
| ispartof | PLoS neglected tropical diseases, 2023-08, Vol.17 (8), p.e0011492-e0011492 |
| issn | 1935-2735 1935-2727 1935-2735 |
| language | eng |
| recordid | cdi_plos_journals_2865533719 |
| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access; Public Library of Science (PLoS) |
| subjects | Aminoglycoside antibiotics Aminoglycosides Biology and Life Sciences Blood tests Care and treatment Clinical trials Complications and side effects Cutaneous leishmaniasis Dermatology Diagnosis FDA approval Gentamicin Health aspects Human health and pathology Infectious diseases Informed consent Leishmaniasis, Cutaneous Lesions Life Sciences Medicine and Health Sciences Parasites Parasitic diseases Paromomycin Patient outcomes Patients Pentamidine isethionate People and places Pharmaceutical sciences Pharmacology Polymerase chain reaction Protocols Protozoa Pruritus Research and Analysis Methods Santé publique et épidémiologie Surveillance Toxicity Travelers Tropical diseases Ulcers Vector-borne diseases |
| title | Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers |
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