drugset / Trial / NCT06449040

Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

NCT06449040

RandomizedParallel-groupDouble-blindTreatment

Summary

A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).

Timeline

Start
2019-03-01
Primary completion
2021-09-01
Completion
2023-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amphotericin B Unknown 12 mg/kg Intravenous
Comparator Amphotericin B Unknown 18 mg/kg Intravenous
Comparator Amphotericin B Unknown 24 mg/kg Intravenous