Status:
COMPLETED
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
Lead Sponsor:
Hospital Universitário Professor Edgard Santos
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Oswaldo Cruz Foundation
Conditions:
Cutaneous Leishmaniasis, American
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 purpos...
Detailed Description
The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5 Sm29 was used a...
Eligibility Criteria
Inclusion
- \- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.
Exclusion
- Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06000514
Start Date
January 17 2019
End Date
July 7 2022
Last Update
August 21 2023
Active Locations (1)
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1
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, Brazil, 40000