NCT06798415

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

The Clinical Effect of Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis: Single-arm Open-label Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hayder Adnan Fawzi · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-01-29
• Last updated: 2025-02-14

Locations

1 site across 1 country: Iraq