NCT00471705View on ClinicalTrials.gov

Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

PHASE3CompletedINTERVENTIONAL
Enrollment

437

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

December 31, 2009

Conditions
Cutaneous Leishmaniasis
Interventions
DRUG

Miltefosine

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

DEVICE

Thermotherapy

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

DRUG

Glucantime®

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

Trial Locations (1)

1226

Program for Research and Control in Tropical Diseases - PECET, Medellín

All Listed Sponsors
collaborator

Dirección de Sanidad del Ejército de Colombia (DISAN)

UNKNOWN

collaborator

Ministerio de Salud y Protección Social, Colombia

UNKNOWN

lead

Universidad de Antioquia

OTHER

NCT00471705 - Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia. | Biotech Hunter | Biotech Hunter