NCT00257530

Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Imiquimod

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-11-23
• Last updated: 2008-06-12

Locations

2 sites across 1 country: Peru