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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

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

Locations
Other Locations
Iraq
Mustansiriyah University
RECRUITING
Baghdad
Contact Information
Primary
Hayder Adnan Fawzi, PhD
haider-pharm@almustafauniversity.edu.iq
07800106177
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 40
Treatments
Experimental: Intralesional 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 will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.
Related Therapeutic Areas
Sponsors
Leads: Hayder Adnan Fawzi

This content was sourced from clinicaltrials.gov