Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06798415

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Led by Hayder Adnan Fawzi · Updated on 2025-02-14

40

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis
Not Eligible

You will not qualify if you...

  • Immunocompromised
  • Allergic reaction to treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mustansiriyah University

Baghdad, Iraq, 10054

Actively Recruiting

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Research Team

H

Hayder Adnan Fawzi, PhD

CONTACT

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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Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis | DecenTrialz