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Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World

NCT04515186 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-05-08

No results posted yet for this study

Summary

This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.

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

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Paulo Machado · Federal University of Bahia

  • Marcia Hueb · Julio Muller University Hospital Federal University of Mato Grosso

  • Fiorela Yuly Alvarez Romero · Universidad Peruana Cayetano Heredia

  • Juan Miguel Pascale · Instituto Conmemorativo Gorgas de Estudios de la Salud

  • Jaime Soto · Fundación Nacional de Dermatología

  • Glaucia Cota · Instituto René Rachou Oswaldo Cruz Foundation- FIOCRUZ MINAS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2023-11-10
Completion
2024-02-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • Bolivia
  • Brazil
  • Panama
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515186 on ClinicalTrials.gov