Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00233545
Study type	Interventional
Source	AB Foundation
Contact
Status	Completed
Phase	Phase 2
Start date	September 2005
Completion date	September 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01988909` - WR 279,396 for the Treatment of Cutaneous Leishmaniasis	Phase 2
Enrolling by invitation	`NCT00840359` - Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis	Phase 2
Enrolling by invitation	`NCT00737386` - Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank	N/A
Completed	`NCT01462500` - Pharmacokinetics of Miltefosine in Children and Adults	Phase 4
Completed	`NCT01011309` - A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis	Phase 2
Completed	`NCT01301924` - Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis	Phase 2/Phase 3
Not yet recruiting	`NCT02281669` - Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients	N/A
Completed	`NCT01464242` - Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis	Phase 2/Phase 3
Completed	`NCT01790659` - Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama	Phase 3
Completed	`NCT01050907` - Miltefosine to Treat Mucocutaneous Leishmaniasis	Phase 2
Completed	`NCT04340128` - Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)	Phase 3
Terminated	`NCT00317629` - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Phase 3
Completed	`NCT00351520` - Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica	Phase 3
Completed	`NCT01381055` - Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis	Phase 2/Phase 3
Completed	`NCT01050777` - Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis	Phase 0
Completed	`NCT01380314` - Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis	Phase 2
Terminated	`NCT01380301` - Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony	Phase 2
Completed	`NCT00703924` - Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World	Phase 2
Completed	`NCT00344084` - Surveillance for Leishmaniasis Skin Lesions in Mali
Completed	`NCT03023111` - Miltefosine and GM-CSF in Cutaneous Leishmaniasis	Phase 3