Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
- Conditions
- Cutaneous Leishmaniasis, American
- Interventions
- Drug: Sm29 Protein, Schistosoma Mansoni
- Registration Number
- NCT06000514
- Lead Sponsor
- Hospital Universitário Professor Edgard Santos
- 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 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.
- 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 at a dose of 10ug applied twice a day for 20 days. A phase I study was also carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29 applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients, Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days. Patients were evaluated on days 10, 20 and 30 for adverse reactions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.
- Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical Sm29 and Sbv Pentavalent antimony (Sbv) Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days Topical Placebo and Sbv Pentavalent antimony (Sbv) Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days Topical Sm29 and Sbv Sm29 Protein, Schistosoma Mansoni Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days
- Primary Outcome Measures
Name Time Method Cure 90 days Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Corte de Pedra Health Post
🇧🇷Presidente Tancredo Neves, Bahia, Brazil
Corte de Pedra Health Post🇧🇷Presidente Tancredo Neves, Bahia, Brazil