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
Sponsors and collaborators
Hayder Adnan Fawzi
Lead sponsor
Al-Mustafa University College
Sponsor institution