Actively Recruiting
Clinical Effect of Intralesional Metronidazole Injection for Cutaneous Leishmaniasis Management: Open-label Single-arm Trial
Led by Hayder Adnan Fawzi · Updated on 2025-02-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of intralesional metronidazole 0.5% solution as a local injection to treat cutaneous leishmaniasis. This open-label, single-arm phase 2 trial aims to evaluate the cure rate of cutaneous leishmaniasis lesions following this treatment. The study focuses on patients with one or multiple skin lesions caused by this condition. Participants will receive intralesional metronidazole injections based on lesion size, with a dose of 5 mg per cm2, using a fine insulin needle. The treatment is administered once weekly for up to 6 weeks, but if lesions heal earlier, treatment will stop and only assessments will continue. Each lesion is treated individually and followed for up to 90 days or until cured. During the study, patients will have their lesions monitored regularly to assess healing. Researchers will measure the cure rate from enrollment through treatment and follow-up. No local anesthesia is used during injections, and the volume injected varies by lesion size. Participants can expect weekly visits for up to 6 weeks for treatment and additional follow-ups until 90 days after starting treatment.
CONDITIONS
Brief Title
Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with single or multiple (less than seven) lesions of cutaneous leishmaniasis
- Age between 18 and 80 years
- All genders are eligible
You will not qualify if you...
- Immunocompromised individuals
- History of allergic reaction to the treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive weekly intralesional injections of metronidazole into each lesion based on its size. Treatment continues for up to 6 weeks or until the participant is cured.
Weekly visits for up to 6 weeks
Duration - Up to 90 days from enrollment to end of treatment
Participants who are cured before 6 weeks are asked to come for lesion assessment visits to monitor recovery.
Visits as needed for lesion assessment after treatment ends
Trial Site Locations
Total: 1 location
1
Mustansiriyah University
Baghdad, Iraq, 10054
Actively Recruiting
Research Team
H
Hayder Adnan Fawzi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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