Clinical Trials Logo

Clinical Trial Summary

Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been described in up to 50% of patients, and the long period of 60 to 90 days required for healing of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited either by toxicity or because, as with Sbv, the parenteral route hinders adherence and regularity of treatment in the rural area. Recent studies by our group indicate that oral miltefosine is the most effective drug for the treatment of patients with CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03023111
Study type Interventional
Source Hospital Universitário Professor Edgard Santos
Contact
Status Completed
Phase Phase 3
Start date June 30, 2017
Completion date February 14, 2020

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 NCT00233545 - Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia Phase 2
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