cutaneous leishmaniasis
Conditions
Interventions
During the experimental treatment period, healthy volunteers will be individually monitored by a clinical record to record the clinical history, follow-up schedule, days of examinations and the result
D20.280.260
Sponsors
Universidade Federal do Amazonas - UFAM
INPA - Instituto Nacional de Pesquisas da Amazônia
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 70 years; both genders; Individuals considered healthy after initial clinical and laboratory evaluation; Agreement and voluntary signature of the free and informed consent form
Exclusion criteria
Exclusion criteria: Individuals who present alterations in the pre-treatment clinical and/or laboratory assessment; History of visceral leishmaniasis or American cutaneous leishmaniasis; Liver or kidney dysfunction, diabetes or heart disease; Allergy to the experimental treatment; Pregnant and lactating women; Alcoholics, smokers or those using medication; Patients with chronic diseases and/or infectious diseases such as tuberculosis, leprosy, human immunodeficiency virus, visceral leishmaniasis or American cutaneous leishmaniasis, among others; Patients with a medical history of visceral leishmaniasis or American cutaneous leishmaniasis; Inability or refusal to sign the informed consent form or inability to comply with the experimental protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected with this project that the pharmaceutical compound in topical formulation with the purpose of combating the Leishmaniasis parasite is safe, with no adverse effect in phase 1 tests, thus being able to proceed to phase 2 tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactThiago Bacha
Universidade Federal do Amazonas - UFAM
Outcome results
None listed