{Reference Type}: Clinical Trial, Phase II
{Title}: Treatment of cutaneous leishmaniasis with a sequential scheme of pentamidine and tamoxifen in an area with a predominance of Leishmania (Viannia) guyanensis: A randomised, non-inferiority clinical trial.
{Author}: Pennini SN;de Oliveira Guerra JA;Rebello PFB;Abtibol-Bernardino MR;de Castro LL;da Silva Balieiro AA;de Oliveira Ferreira C;Noronha AB;Dos Santos da Silva CG;Leturiondo AL;Vital de Jesus D;de Araújo Santos FJ;Chrusciak-Talhari A;Guerra MDGVB;Talhari S;
{Journal}: Trop Med Int Health
{Volume}: 28
{Issue}: 12
{Year}: 2023 12 8
{Factor}: 3.918
{DOI}: 10.1111/tmi.13943
{Abstract}: To determine whether a combination of a single intramuscular (IM) dose of pentamidine (7 mg/kg) followed by oral tamoxifen 40 mg/day for 20 days is non-inferior to three IM doses of pentamidine 7 mg/kg in the treatment of cutaneous leishmaniasis with a margin of 15%.<BR>Phase II, randomised, controlled, open-label, non-inferiority clinical trial. Primary outcome was the complete healing of the lesions 6 months after starting treatment. Secondary outcomes were healing 3 months after starting treatment and determining the presence and severity of adverse effects (AE).<BR>The research was concluded with 49 patients; Leishmania (Viannia) guyanensis was the most frequent species isolated. In the primary outcome, 18 (72%) (95% CI: 52.4%-85.7%) of the 25 patients allocated to the intervention group and 24 (100%) (95% CI: 86.2%-100%) of the control group (p = 0.015) met the established criteria of cure. There was no AE with tamoxifen.<BR>Although a 72% cure rate presented by the combination of tamoxifen and pentamidine was lower than in the control group that achieved a 100% cure, it is still a safe and is a clinically relevant result. It indicates that the therapeutic scheme evaluated may be a promising option for populations in remote areas, however it should be further studied, in order to include a larger number of patients.