Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: Miltefosine; Thermotherapy; Glucantime®
Intervention description: Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.; One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.; Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
Intervention MeSH terms: Miltefosine; Meglumine Antimoniate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Miltefosine; Leishmaniasis; Glucantime; Thermotherapy; Colombia

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)