Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Association of Topical Sm29 in Gold Nanoparticles With Intravenous Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania Braziliensis: A Randomized Controlled Trial.

Conditions
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Cutaneous Leishmaniasis, American

Intervention / Treatment
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* Drug: Sm29 Protein, Schistosoma Mansoni
* Drug: Pentavalent antimony (Sbv)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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 Criteria: Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized and controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Sm29 and Sbv<br>Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days | Drug: Sm29 Protein, Schistosoma Mansoni<br>* Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.<br>* Other names: Pentavalent antimony (Sbv);Drug: Pentavalent antimony (Sbv)<br>* Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.<br>* Other names: Placebo cream;|
| Placebo Comparator: Topical Placebo and Sbv<br>Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days | Drug: Pentavalent antimony (Sbv)<br>* Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.<br>* Other names: Placebo cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure | Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Leishmaniasis, Sm29, L. braziliensis