Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

Recruiting now · Phase 2

Conditions studied: Cutaneous Leishmaniasis

In brief

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.

Key facts

Study ID

NCT06797544

Run by

Hayder Adnan Fawzi

People needed

40

Starts

2025-02-09

Expected to finish

2025-11-01

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis and patients ranging in age from 20 to 75 years old.

You may not qualify if…

• Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study and patients on prolonged corticosteroid therapy.

Where it is running

• Mustansiriyah University — Baghdad, Iraq (enrolling)

Full record on ClinicalTrials.gov

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