Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown
an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000
new cases of CL were diagnosed in Colombia.
So far, pentavalent antimony compounds have been considered the treatment of choice with a
percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by
their adverse events and disadvantages. Previous studies have shown that miltefosine could be
a potential alternative of treatment for CL.
The main objective of this study is to evaluate the efficacy and safety of miltefosine or
thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of
miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50
celsius degrees during 30 seconds will be compared with the standard treatment of
intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days
in CL parasitologically proven patients.
This trial will be conducted according to the International approved GCP (Good Clinical
Practice) guidelines.
Phase:
Phase 3
Details
Lead Sponsor:
Universidad de Antioquia
Collaborators:
Dirección de Sanidad del Ejército de Colombia (DISAN) Ministerio de Salud y Protección Social, Colombia