Tamoxifen and meglumine antimoniate combined therapy in cutaneous leishmaniasis patients: a randomised trial

Objectives There is a clear need for new strategies of leishmaniasis treatment. This work was conducted to evaluate the efficacy of the co‐administration of tamoxifen and meglumine antimoniate (SbV) in a phase II pilot clinical trial in localised cutaneous leishmaniasis patients. Methods A randomised controlled pilot clinical trial was conducted to evaluate the efficacy and safety of oral (40 mg/day for 20 days) or topical tamoxifen (0.1% tamoxifen citrate for 20 days) combined with meglumine antimoniate (20 mg SbV/kg/day for 20 days) vs. a standard SbV protocol (20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis. Primary outcome was complete epithelisation of the lesion 6 months after the end of treatment. Secondary outcomes were lesion healing 2 months after the end of treatment and frequency and severity of adverse events. Results A total of 38 subjects were included in the trial, 15 were treated with standard SbV and 23 with the combination of tamoxifen and SbV. Of the patients treated with the co‐administration scheme, 12 received tamoxifen orally and 11 were treated with topical tamoxifen. Tamoxifen administered by the oral or topical routes was well tolerated. Cure rates 6 months after the end of treatment per intention to treat were 40% in the group treated with the standard SbV scheme, and 36.4% and 58%, respectively, for groups treated with SbV plus topical or oral tamoxifen. Conclusions In the doses and schemes used in this study, co‐administration of oral tamoxifen and SbV resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels. Objectifs Il y a un besoin évident de nouvelles stratégies de traitement de la leishmaniose. Ce travail a été mené pour évaluer l'efficacité de l'administration concomitante de tamoxifène et d'antimoniate de méglumine (SbV) dans un essai clinique pilote de phase II chez des patients atteints de leishmaniose cutanée localisée. Méthodes Un essai clinique pilote contrôlé randomisé a été mené pour évaluer l'efficacité et la sécurité du tamoxifène oral (40 mg/jour pendant 20 jours) ou topique (citrate de tamoxifène à 0.1% pendant 20 jours) combiné avec l'antimoniate de méglumine (20 mg SbV/kg/jour pendant 20 jours) par rapport à un protocole standard (20 mg SbV/kg/jour pendant 20 jours) pour le traitement de la leishmaniose cutanée. Le résultat principal était l’épithélisation complète de la lésion 6 mois après la fin du traitemen