The topical treatment of old world cutaneous leishmaniasis with gentian violet along with cryotherapy: a pilot single-blind randomized controlled clinical trial

Abstract INTRODUCTION: The promising non-clinical antileishmanial effects of gentian violet (GV) encouraged us to evaluate the additive effect of GV on cryotherapy. METHODS: For 8 weeks, 59/161 cutaneous leishmaniasis patients/lesions underwent cryotherapy alone (group 1) or cryotherapy accompanied by 1% GV application (group 2). The primary endpoint was clinical response. RESULTS: Ultimately, 54.7% and 45.3% of the significantly cured lesions belonged to groups 1 and 2, respectively, which was not statistically significant. The clinical response was significantly different between the two groups at the end of the fourth week. CONCLUSIONS: Although the clinical response of the two groups was significantly different at the end of the fourth week, application of GV did not increase the efficacy of cryotherapy.