Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis

Sponsor
Hospital Universitário Professor Edgard Santos
Study ID
NCT06011343
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Cutaneous Leishmaniasis, American

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral tofacitinib — DRUG
    Association of tofacitinib and meglumine antimoniate
  • Parenteral meglumine antimoniate — DRUG
    Meglumine antimoniate

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Aug 2023
Primary completion
Oct 1, 2024
Completion
Jul 1, 2025

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo and Sbv
    Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
  • Experimental: Tofacitinib and Sbv
    Eleven CL patients will receive oral tofatinib (10mg daily for 30 days) associated to meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.

Primary Outcome Measure

Cure at 90 days [ Time Frame: 90 days ]

Central Contacts