Tofacitinib Associated With Meglumine Antimoniate in the Control of American Tegumentary Leishmaniasis. A Randomized and Controlled Clinical Trial.

CL Tofa23

Phase 2/3 randomized and controlled clinical trial, which will evaluate the effectiveness of the association meglumine antimoniate (Glucantime) with tofacitinib in the cure of CL and the capacity of this association to reduce the time of cure of the disease.

2023-10-01

2024-10-01

2025-07-01

Not yet recruiting

Early phase I

22

Inclusion Criteria: * Subjects with CL of both sexes with disease duration between 30 and 90 days. Patients with CL will be treatment-naïve for leishmaniasis. Individuals will be explained about the nature of the study and will only be included if they agree to participate and sign the Free and Informed Consent Form. Exclusion Criteria: * Patients under the age of 18 and pregnant women will not participate in the study considering the need to withdraw 30 ml of blood to carry out the studies of the immune response. Patients over 60 years old, debilitating chronic diseases such as heart failure, liver failure, kidney failure, HIV infection and use of immunosuppressant drugs will also not participate in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'CL patients will be allocated in 2 intervention groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'After randomization and allocation each patient will receive a code that will be confidential.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ESTIMATED'}}

2023-08-25