Status:
UNKNOWN
Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
Lead Sponsor:
Hospital Universitário Professor Edgard Santos
Collaborating Sponsors:
Instituto Gonçalo Muniz FIOCRUZ BA
Conditions:
Cutaneous Leishmaniasis, American
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
1. STUDY AREA The southeastern region of the State of Bahia, Brazil, where the village of Corte de Pedra and adjacent towns are located, is one of the most important American Tegumentary Leishmaniasis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06011343
Start Date
October 1 2023
End Date
July 1 2025
Last Update
August 25 2023
Active Locations (1)
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1
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, Brazil, 40000