drugset / Trial / NCT06797544

Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

NCT06797544

Phase 2 Recruiting 40 enrolled Hayder Adnan Fawzi
NaSingle-groupOpen-labelTreatment

Summary

Aim of the study to evaluate the effectiveness of intralesional levofloxacin 0.5% solution as a local injection in treating cutaneous leishmaniasis. In an open-label single-arm clinical trial, all patients were given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured. Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment. A fine insulin needle will be used to infiltrate the lesion.

Timeline

Start
2025-02-09
Primary completion
2025-11-01
Completion
2025-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Levofloxacin Small molecule Other