%0 Clinical Trial, Phase II
%T 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.
%A Pennini SN
%A de Oliveira Guerra JA
%A Rebello PFB
%A Abtibol-Bernardino MR
%A de Castro LL
%A da Silva Balieiro AA
%A de Oliveira Ferreira C
%A Noronha AB
%A Dos Santos da Silva CG
%A Leturiondo AL
%A Vital de Jesus D
%A de Araújo Santos FJ
%A Chrusciak-Talhari A
%A Guerra MDGVB
%A Talhari S
%J Trop Med Int Health
%V 28
%N 12
%D 2023 12 8
%M 37936525
%F 3.918
%R 10.1111/tmi.13943
%X 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%.
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).
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.
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.