drugset / Trial / NCT06000514
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
Phase 1/2
Completed
20 enrolled
Hospital Universitário Professor Edgard Santos
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collabOswaldo Cruz Foundation · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.
Timeline
- Start
- 2019-01-17
- Primary completion
- 2022-04-06
- Completion
- 2022-07-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sm29 | Protein / enzyme biologic | 5 ug | Topical |
| Subject | Sm29 | Protein / enzyme biologic | 10 ug | Topical |
| Background | Meglumine antimonate | Other / unclassified | 20 mg/kg | Intravenous |