Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World

PHASE3CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

November 10, 2023

Study Completion Date

February 27, 2024

Conditions
Cutaneous Leishmaniases
Interventions
DRUG

Meglumine Antimoniate

Vials of a 5mL solution. Each vial contains 405 mg of Sb5+ corresponding to 8.1% Sb5+ (81 mg/mL).

DRUG

Miltefosine

50 mg capsule

DEVICE

Thermotherapy machine

Localized Current Field radio-frequency generating device

Trial Locations (6)

Unknown

Fundación Nacional de Dermatología, Santa Cruz de la Sierra

Instituto René Rachou Oswaldo Cruz Foundation- FIOCRUZ MINAS, Belo Horizonte

Julio Muller University Hospital Federal University of Mato Grosso, Cuiabá

Federal University of Bahia Immunology Department, Salvador

Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama City

Universidad Peruana Cayetano Heredia, Lima

All Listed Sponsors
lead

Drugs for Neglected Diseases

OTHER

NCT04515186 - Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World | Biotech Hunter | Biotech Hunter