NCT03023111View on ClinicalTrials.gov

Miltefosine and GM-CSF in Cutaneous Leishmaniasis

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2017

Primary Completion Date

August 9, 2019

Study Completion Date

February 14, 2020

Conditions
Cutaneous Leishmaniasis
Interventions
DRUG

Sbv

Standard treatment for CL, parenteral drug used during 20 days.

DRUG

Miltefosine plus placebo

Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. Placebo gel cream will be used topically.

DRUG

Miltefosine plus GM-CSF

Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. GM-CSF gel cream will be used topically.

Trial Locations (2)

40000

Corte de Pedra Health Post, Presidente Tancredo Neves

69.040-000

Fundação de Medicina Tropical do Amazonas, Manaus

All Listed Sponsors
collaborator

Oswaldo Cruz Foundation

OTHER

lead

Hospital Universitário Professor Edgard Santos

OTHER

NCT03023111 - Miltefosine and GM-CSF in Cutaneous Leishmaniasis | Biotech Hunter | Biotech Hunter