1. Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial.
- Author
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Lago T, Peixoto F, Mambelli F, Carvalho LP, Guimarães LH, Carvalho AM, Cardoso L, Machado PRL, Scott P, Lago J, Andrade JM, Fahel JS, Oliveira SC, and Carvalho EM
- Subjects
- Humans, Male, Female, Adult, Middle Aged, Young Adult, Treatment Outcome, Meglumine administration & dosage, Meglumine therapeutic use, Adolescent, Animals, Leishmania braziliensis drug effects, Administration, Intravenous, Granzymes metabolism, Leishmaniasis, Cutaneous drug therapy, Leishmaniasis, Cutaneous parasitology, Meglumine Antimoniate therapeutic use, Meglumine Antimoniate administration & dosage, Antiprotozoal Agents therapeutic use, Antiprotozoal Agents administration & dosage, Administration, Topical, Drug Therapy, Combination, Organometallic Compounds therapeutic use, Organometallic Compounds administration & dosage
- 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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
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