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Clinical Trial
. 2018 Jun 21;113(9):e180200.
doi: 10.1590/0074-02760180200.

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

Dario Brock Ramalho  1 , Rosiana Estéfane da Silva  2 , Maria Camilo Ribeiro de Senna  2 , Hugo Silva Assis Moreira  2 , Mariana Junqueira Pedras  2 , Daniel Moreira de Avelar  2 , Lara Saraiva  2 , Ana Rabello  2 , Gláucia Cota  2
Affiliations
Clinical Trial

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

Dario Brock Ramalho et al. Mem Inst Oswaldo Cruz. .

Abstract

Background: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.

Objectives: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL.

Methods: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations.

Results: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

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Figures

Fig. 1:
Fig. 1:. the standard operational procedure for the meglumine antimonial intralesional infiltration technique.
Fig. 2:
Fig. 2:. study flowchart according CONSORT stands.
Fig. 3:
Fig. 3:. (A) The first day of the treatment (D1); (B) 42 days from the beginning of the treatment (D42); (C) 90 days from the beginning of the treatment (D90).
See this image and copyright information in PMC

References

    1. Cota GF, de Sousa MR, Fereguetti TO, Saleme PS, Alvarisa TK, Rabello A. The cure rate after placebo or no therapy in American cutaneous leishmaniasis a systematic review and meta-analysis. PLoS One. 2016;11(2):e0149697. - PMC - PubMed
    1. Bruschi F, Gradoni L. The leishmaniases: old neglected tropical diseases. 1. Milan: Springer International Publishing; 2018.
    1. Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E. Local or systemic treatment for New World cutaneous leishmaniasis Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012;4(3):153–163. - PubMed
    1. Brito NC, Rabello A, Cota GF. Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis a systematic review. PLoS One. 2017;12(9):e0184777. - PMC - PubMed
    1. WHO - World Health Organization . Report of a meeting of the WHO Expert Committee on the control of leishmaniases. Geneva: WHO technical report series 949; 2010.

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