{"doi":"10.1016/j.ijid.2024.107206","title":"Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial","abstract":"BACKGROUND: Cutaneous leishmaniasis (CL) caused by Leishmania (Viannia) braziliensis is associated with an inflammatory response. Granzyme (GzmB) and IL-1β play a key role in the pathology. Meglumine antimoniate (MA) is the first-choice drug for the treatment of CL, but therapy failure is observed in up to 50% of the cases. The protein, rSm29 of Schistosoma mansoni, down-modulates pro-inflammatory cytokine production. We evaluate if the combination of topical rSm29 plus MA increases the cure rate of CL. METHODS: In this randomized clinical trial, 91 CL patients were allocated in 3 groups. All cases received MA (20 mg/kg/weight) for 20 days. Group 1 used topical rSm29 (10 µg), group 2 a placebo topically applied, and group 3 received only MA. RESULTS: The cure rate on day 90 was 71% in subjects treated with rSm29 plus MA, and 43% in patients who received MA plus placebo or MA alone (P < 0.05). There was a decrease in GzmB and an increase in IFN-γ (P < 0.05) in supernatants of skin biopsies of the lesions obtained on D7 of therapy (P < 0.05) in patients who received rSm29. CONCLUSION: rSm29 associated with MA reduces GzmB levels, is more effective than MA alone, and decreases CL healing time. CLINICAL TRIALS REGISTRATION: ClinicalTrial.gov under NCT06000514.","journal":"International Journal of Infectious Diseases","year":2024,"id":468824,"datarank":0.22428147544486693,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.016337321276883324,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.016337321276883324,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":2,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9604,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT06000514"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":784694,"name":"Fábio Peixoto","orcid":"0000-0003-3804-8192","position":1,"is_corresponding":false},{"id":766563,"name":"Fábio Mambelli","orcid":"0000-0002-8956-7219","position":2,"is_corresponding":false},{"id":416443,"name":"Lucas P. Carvalho","orcid":"0000-0001-5033-1666","position":3,"is_corresponding":false},{"id":416442,"name":"Luiz Henrique Guimarães","orcid":"0000-0002-0202-5661","position":4,"is_corresponding":false},{"id":416441,"name":"Augusto M. Carvalho","orcid":"0000-0002-8031-4805","position":5,"is_corresponding":false},{"id":1301858,"name":"Luciana Santos Cardoso","orcid":"0000-0001-9195-451X","position":6,"is_corresponding":false},{"id":446002,"name":"Paulo Roberto Lima Machado","orcid":"0000-0003-1894-6171","position":7,"is_corresponding":false},{"id":58045,"name":"Phillip Scott","orcid":"0000-0001-8732-0653","position":8,"is_corresponding":false},{"id":446001,"name":"Jamile Lago","orcid":"0000-0002-5865-6163","position":9,"is_corresponding":false},{"id":1301859,"name":"Juvana Moreira Andrade","orcid":"0009-0000-0100-0027","position":10,"is_corresponding":false},{"id":369632,"name":"Júlia S. Fahel","orcid":"0000-0003-2580-0189","position":11,"is_corresponding":false},{"id":269886,"name":"Sérgio C. Oliveira","orcid":"0000-0003-4062-5577","position":12,"is_corresponding":false},{"id":416445,"name":"Edgar M. Carvalho","orcid":"0000-0002-2697-8002","position":13,"is_corresponding":false},{"id":498495,"name":"Tainã Lago","orcid":null,"position":0,"is_corresponding":true}],"reference_count":30,"raw_metadata":null,"created_at":"2026-07-19T02:05:23.500722Z","pmid":"39147194","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}