{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T01:10:21Z","timestamp":1792285821779,"version":"4.4.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2023,4,26]],"date-time":"2023-04-26T00:00:00Z","timestamp":1682467200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,8,22]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL). Uncontrolled studies suggest that intralesional MA (IL-MA) may be noninferior and safer than systemic MA (S-MA).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Multicenter, randomized, controlled, open-label, phase 3 clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared with S-MA (10\u201320 mg Sb5+\/kg\/day, 20 days) for CL, with noninferiority margin of 20%. Primary and secondary outcomes were definitive cure at day 180 and epithelialization rate at day 90 of treatment, respectively. A 2-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AEs) were monitored according to the Division of AIDS AE grading system.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We evaluated 135 patients. The cure rates (95% confidence interval) for IL-MA and S-MA treatment were, respectively, 82.8% (70.5\u201391.4) and 67.8% (53.3\u201378.3) per protocol (PP) and 70.6% (58.3\u201381.0) and 59.7% (47.0\u201371.5) per intention to treat (ITT). The epithelialization rates of the IL-MA and S-MA treatment were, respectively, 79.3% (66.6\u201388 + 8) and 71.2% (57.9\u201382.2) PP and 69.1% (55.2\u201378.5) and 64.2% (50.0\u201374.2) ITT. AEs in the IL-MA and S-MA groups were, respectively, clinical, 45.6% and 80.6%; laboratory, 26.5% and 73.1%; and electrocardiogram, 8.8% and 25.4%. Ten participants in the S-MA group and 1 in the IL-MA group were discontinued due to severe or persistent AEs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>IL-MA provides a similar cure rate and results in less toxicity compared with S-MA and may be used as first-line therapy for CL patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>REBEC: RBR-6mk5n4.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciad253","type":"journal-article","created":{"date-parts":[[2023,4,26]],"date-time":"2023-04-26T22:35:45Z","timestamp":1682548545000},"page":"574-582","source":"Crossref","is-referenced-by-count":11,"title":["A Randomized, Controlled, Noninferiority, Multicenter Trial of Systemic vs Intralesional Treatment With Meglumine Antimoniate for Cutaneous Leishmaniasis in Brazil"],"prefix":"10.1093","volume":"77","author":[{"given":"Marcelo R","family":"Lyra","sequence":"first","affiliation":[{"name":"Laboratory of Clinical Research and Surveillance in Leishmaniasis, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliane F A","family":"Oliveira","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Research and Surveillance in Leishmaniasis, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armando O","family":"Schubach","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Research and Surveillance in Leishmaniasis, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raimunda N R","family":"Sampaio","sequence":"additional","affiliation":[{"name":"Dermatology Service of Internal Medicine, Faculty of Medicine of the University of Bras\u00edlia , Bras\u00edlia, DF , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruna C","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Dermatology Service of Internal Medicine, Faculty of Medicine of the University of Bras\u00edlia , Bras\u00edlia, DF , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcia","family":"Hueb","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Julio Muller University Hospital, Federal University of Mato Grosso , Cuiab\u00e1, Mato Grosso , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gl\u00e1ucia","family":"Cota","sequence":"additional","affiliation":[{"name":"Clinical Research and Public Policies in Infectious Diseases, Ren\u00e9 Rachou Institute, Fiocruz Minas , Belo Horizonte, MG , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosiana E","family":"Silva","sequence":"additional","affiliation":[{"name":"Clinical Research and Public Policies in Infectious Diseases, Ren\u00e9 Rachou Institute, Fiocruz Minas , Belo Horizonte, MG , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Francesconi","sequence":"additional","affiliation":[{"name":"Dermatology Department, Heitor Vieira Dourado Tropical Medicine Foundation , Manaus, AM , Brazil"},{"name":"Dermatology Department, Federal University of Amazonas , Manaus, AM , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maur\u00edcio A","family":"Pompilio","sequence":"additional","affiliation":[{"name":"Faculty of Medicine of the Federal University of Mato Grosso do Sul , Campo Grande, Mato Grosso do Sul , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana O","family":"Fran\u00e7a","sequence":"additional","affiliation":[{"name":"Faculty of Medicine of the Federal University of Mato Grosso do Sul , Campo Grande, Mato Grosso do Sul , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valdir S","family":"Amato","sequence":"additional","affiliation":[{"name":"Laboratory of Parasitology, Institute of Tropical Medicine, Faculty of Medicine, University of S\u00e3o Paulo , S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina M","family":"Souza","sequence":"additional","affiliation":[{"name":"Laboratory of Parasitology, Institute of Tropical Medicine, Faculty of Medicine, University of S\u00e3o Paulo , S\u00e3o Paulo , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel V C","family":"Oliveira","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Epidemiology, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cl\u00e1udia M","family":"Valete","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Research and Surveillance in Leishmaniasis, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , Brazil"},{"name":"Department of Otorhinolaryngology and Ophthalmology, Faculty of Medicine of Federal University of Rio de Janeiro , Rio de Janeiro , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria I F","family":"Pimentel","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Research and Surveillance in Leishmaniasis, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation , Rio de Janeiro , 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