Phase 3
N=437
Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT00471705 ↗Enrolled (actual)
437
Serious AEs
0.9%
Results posted
Jul 2010
Primary outcome: Primary: Complete Clinical Response — 85; 103; 86 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Miltefosine (Drug); Thermotherapy (Device); Glucantime® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Universidad de Antioquia
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clinical Response |
85; 103; 86 | — |
| PRIMARY Failure |
34; 14; 42 | — |
| SECONDARY Recurrence |
3; 4; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Parasitologically proven cases of CL based on positive smear and/or culture.
- Patients belonging to the National Colombian Army.
- Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
- Age 18-40 years.
- Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits.
- Abstain to receive any other treatment for CL during the trial and follow-up periods.
- Non purulent lesions.
- Mentally sane volunteers.
- No Leishmaniasis treatment in the six months prior to the recruitment.
- Number of lesions no more than 5
Exclusion criteria
- None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal.
- Serious systemic illnesses (as judged by the physician)
- Patients with mucosal compromise.
- Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test)
Data sourced from ClinicalTrials.gov (NCT00471705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.