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Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Recruiting
18-80 years
All
Phase 2

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Overview

Aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis.

In an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be 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 metronidazole (5 mg/ml, 100 ml, Flagyl®, 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, and patients will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.

Eligibility

Inclusion Criteria:

  • Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion Criteria:

  • Immunocompromised
  • Allergic reaction to treatment.

Study details
    Cutaneous Leishmaniasis

NCT06798415

Hayder Adnan Fawzi

14 October 2025

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