A Phase 2 interventional study of Metronidazole in Cutaneous Leishmaniasis, sponsored by Hayder Adnan Fawzi. Recruiting at 1 site in Iraq. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Hayder Adnan Fawzi · Phase 2, Interventional, and Treatment
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.
110 studies on the registry are indexed under Leishmaniasis, Cutaneous; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 63 across 83 interventional studies indexed under Leishmaniasis, Cutaneous.
Browse Leishmaniasis, Cutaneous studies →Hayder Adnan Fawzi is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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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.
Drug: Metronidazole
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 were only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion. The lesion will be thoroughly infiltrated with the drug solution until the base will be completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia will be added. The solutions will be injected intralesionally and not subcutaneously.
Cure rate
Patients were followed weekly up to 90 days after the first injection; four parameters were used for assessment as follows according to Sharquie modified leishmania score: 1. Measure the size of the lesion through the surface area 2. Measurement of the induration of the lesion 3. Assess the degree of erythema of the lesion 4. Assess the presence and absence of ulceration The obtained data is converted from numbers into scores. The total score was calculated by adding individual scores. Score 13-16: Mild response. Score 9-12: Moderate response. Score 5-8: Marked response. Score 0-4: Complete response \& clearance Both marked and complete responses are considered as a cure
Time frame: From enrollment to the end of treatment up to 90 days.
Plan to share: Undecided
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Started Feb 2025 (actual). Primary completion is estimated for May 2025, 2 months after the start.
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Studies of the drug tested here: Metronidazole
Hayder Adnan Fawzi