drugset / Trial / NCT00973128
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Phase 2
Completed
40 enrolled
Hospital Universitário Professor Edgard Santos
Fundação de Amparo à Pesquisa do Estado da Bahia · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.
Timeline
- Start
- 2004-02
- Primary completion
- 2006-10
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GMCSF | Protein / enzyme biologic | 400 ug | Other |
| Comparator | Meglumine antimonate | Other / unclassified | 20 mg | — |