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 (Sb ) 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 Sb /kg/day for 20 days) vs. a standard Sb 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 Sb and 23 with the combination of tamoxifen and Sb . 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 Sb scheme, and 36.4% and 58%, respectively, for groups treated with Sb plus topical or oral tamoxifen.

CONCLUSIONS

In the doses and schemes used in this study, co-administration of oral tamoxifen and Sb resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels.