Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.

NCT00471705 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Universidad de Antioquia
Phase	Phase 3
Status	COMPLETED
Enrolment	437
Start date	2006-06
Completion	2009-12

Conditions

• Cutaneous Leishmaniasis

Interventions

• Miltefosine
• Thermotherapy
• Glucantime®

Primary outcomes

• Complete Clinical Response — Until 6 months posttreatment
  Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment. Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment.
• Failure — Until 3 months posttreatment
  At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment

Countries

Colombia