Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Phase 2

Completed

• Conditions: Cutaneous Leishmaniasis

• Registration Number: NCT00233545
• Lead Sponsor: AB Foundation

Brief Summary

Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Study Completion: 2007-09
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-29
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cure rate

Trial Locations

Locations (1)

Puesto de Salud, Campamento OSCAR,; 🇧🇴 Palos Blancos,, Bolivia