Intralesional Injection of Metronidazole 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 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.

Key facts

Study ID

NCT06798415

Run by

Hayder Adnan Fawzi

People needed

40

Starts

2025-02-10

Expected to finish

2025-05-01

Last updated by the study team

2025-02-14

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

You may not qualify if…

• Immunocompromised
• Allergic reaction to treatment.

Where it is running

• Mustansiriyah University — Baghdad, Iraq (enrolling)

Full record on ClinicalTrials.gov

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