Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHayder Adnan Fawzi

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Immunocompromised

Allergic reaction to treatment.

Trial design

Treatments tested in this trial

  • Metronidazole

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hayder Adnan Fawzi

Lead sponsor

Al-Mustafa University College

Sponsor institution