Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT02919605
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;
* Age: 16-64 years;
* Sex: male and female patients to eligible ;
* Disease Clinical Evolution not longer than 3 months .
Exclusion Criteria:
* AST \> 3 times the upper limit of normal;
* ALT \> 3 times the upper limit of normal;
* Alkaline phosphatase \> 3 times the upper limit of normal;
* Serum creatinine and urea \> 1.5 times the upper limit of normality;
* Blood glucose above 110 mg / dl;
* Evidence of serious underlying disease ( heart , kidney , liver or lung);
* protein and / or caloric severe malnutrition;
* Any uncompensated or uncontrolled condition like active tuberculosis, malignant disease , severe malaria , HIV, leprosy , systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other infectious disease;
* Pregnant women or who are breastfeeding;
* Lack of ability or willingness to provide informed consent (patient and / or parent / legal representative); lack of availability for the visits or to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
64 Years
Study:
NCT02919605
Study Brief:
Protocol Section:
NCT02919605